Medical device recalls: September 2017

The FDA posted 72 medical device recall records in September 2017, from 7 recall events by 7 companies. 1 is Class I, the most serious category.

Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.

Companies with the most recall events

Zimmer Biomet, Inc. · 1 event, 60 records
Sorin Group Italia SRL - CRF · 1 event, 6 records
Medtronic Vascular Galway DBA Medtronic Ireland · 1 event, 2 records
Firefly Medical, Inc. · 1 event, 1 record
Handicare Usa Inc · 1 event, 1 record
Leonhard Lang Medizintechnik GmbH · 1 event, 1 record, 1 Class I
The Metrix Company · 1 event, 1 record

FDA root cause

Process control · 60
Software design · 6
Process design · 2
Component design/selection · 2
Error in labeling · 1
Device Design · 1

Class I recalls (1)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. ↗Class I
Z-3109-2017 · Leonhard Lang Medizintechnik GmbH · posted Sep 12, 2017 · Terminated
Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and…

Class II recalls (71)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,Class II
Z-3240-2017 · The Metrix Company · posted Sep 29, 2017 · Terminated
The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.
Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator,Class II
Z-3228-2017 · Sorin Group Italia SRL - CRF · posted Sep 28, 2017 · Terminated
There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic…
Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator,Class II
Z-3229-2017 · Sorin Group Italia SRL - CRF · posted Sep 28, 2017 · Terminated
There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic…
Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator,Class II
Z-3230-2017 · Sorin Group Italia SRL - CRF · posted Sep 28, 2017 · Terminated
There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic…
Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator,Class II
Z-3231-2017 · Sorin Group Italia SRL - CRF · posted Sep 28, 2017 · Terminated
There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic…
Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator,Class II
Z-3232-2017 · Sorin Group Italia SRL - CRF · posted Sep 28, 2017 · Terminated
There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic…
Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator,Class II
Z-3233-2017 · Sorin Group Italia SRL - CRF · posted Sep 28, 2017 · Terminated
There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic…
Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601,…Class II
Z-3144-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile ↗Class II
Z-3145-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 00129100400, Nonsterile. orthopedic… ↗Class II
Z-3146-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item Number/EDI 00225503137,… ↗Class II
Z-3147-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile.… ↗Class II
Z-3148-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI… ↗Class II
Z-3149-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500,… ↗Class II
Z-3150-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile. orthopedic surgical… ↗Class II
Z-3151-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical… ↗Class II
Z-3152-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 00480606011, Nonsterile. orthopedic surgical… ↗Class II
Z-3153-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3.5 mm Diameter 195 mm Length, Item Number/EDI… ↗Class II
Z-3154-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile.… ↗Class II
Z-3155-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch) Length, Item Number/EDI… ↗Class II
Z-3156-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI… ↗Class II
Z-3157-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI 00225503332, Nonsterile.… ↗Class II
Z-3158-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Number/EDI 00225503337, Nonsterile.… ↗Class II
Z-3159-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550, Nonsterile. orthopedic surgical… ↗Class II
Z-3160-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile. orthopedic… ↗Class II
Z-3161-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801500, Nonsterile.… ↗Class II
Z-3162-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile.… ↗Class II
Z-3163-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile.… ↗Class II
Z-3164-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item Number/EDI 00231802006, Nonsterile.… ↗Class II
Z-3165-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number/EDI 00231802500, Nonsterile.… ↗Class II
Z-3166-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00231802506, Nonsterile. orthopedic… ↗Class II
Z-3167-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802700, Nonsterile.… ↗Class II
Z-3168-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802706, Nonsterile.… ↗Class II
Z-3169-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803200, Nonsterile.… ↗Class II
Z-3170-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile.… ↗Class II
Z-3171-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803500, Nonsterile.… ↗Class II
Z-3172-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803506, Nonsterile.… ↗Class II
Z-3173-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonsterile. orthopedic surgical instrument. ↗Class II
Z-3174-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonsterile. orthopedic surgical instrument. ↗Class II
Z-3175-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804500, Nonsterile.… ↗Class II
Z-3176-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Drill Bits 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804506, Nonsterile.… ↗Class II
Z-3177-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI… ↗Class II
Z-3178-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connect 2.7 mm O.D., Item Number/EDI… ↗Class II
Z-3179-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI 00236017520, Nonsterile.… ↗Class II
Z-3180-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, Item Number/EDI 00236020527, Nonsterile.… ↗Class II
Z-3181-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Length, Item Number/EDI 00241002000,… ↗Class II
Z-3182-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 12.5 cm Length, Item Number/EDI 00241002100,… ↗Class II
Z-3183-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Length, Item Number/EDI 00241002500,… ↗Class II
Z-3184-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Length, Item Number/EDI 00241002600,… ↗Class II
Z-3185-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length, Item Number/EDI 00241002700,… ↗Class II
Z-3186-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Length, Item Number/EDI 00241003500,… ↗Class II
Z-3187-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Length, Item Number/EDI 00241004000,… ↗Class II
Z-3188-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Zimmer Natural Nail System Calibrated Drill Short 4.9 mm, Item Number/EDI 00249006449, Nonsterile. orthopedic… ↗Class II
Z-3189-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508520, Nonsterile. orthopedic surgical… ↗Class II
Z-3190-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length, Item Number/EDI 00480513032, Nonsterile. orthopedic surgical… ↗Class II
Z-3191-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 00480608515, Nonsterile. orthopedic surgical… ↗Class II
Z-3192-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 00480610020, Nonsterile. orthopedic surgical… ↗Class II
Z-3193-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Quick-Connect 2.7 mm Diameter 100 mm Length, Item Number/EDI 00480610027, Nonsterile. orthopedic surgical… ↗Class II
Z-3194-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 00480611025, Nonsterile. orthopedic surgical… ↗Class II
Z-3195-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 00480611035, Nonsterile. orthopedic surgical… ↗Class II
Z-3196-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 00480614532, Nonsterile. orthopedic surgical… ↗Class II
Z-3197-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill bit Quick-Connect 3-Fluted 2.5 mm Diameter 180 mm Length, Item Number/EDI 00480718025, Nonsterile. orthopedic… ↗Class II
Z-3198-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile. orthopedic… ↗Class II
Z-3199-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, Item Number/EDI 00480723025, Nonsterile.… ↗Class II
Z-3200-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, Item Number/EDI 00249007543, Nonsterile.… ↗Class II
Z-3201-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 00480614545, Nonsterile. orthopedic surgical… ↗Class II
Z-3202-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile. orthopedic surgical… ↗Class II
Z-3203-2017 · Zimmer Biomet, Inc. · posted Sep 22, 2017 · Terminated
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid…Class II
Z-3136-2017 · Medtronic Vascular Galway DBA Medtronic Ireland · posted Sep 20, 2017 · Terminated
Stylette removal difficulties on the Euphora and Solarice products.
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid…Class II
Z-3137-2017 · Medtronic Vascular Galway DBA Medtronic Ireland · posted Sep 20, 2017 · Terminated
Stylette removal difficulties on the Euphora and Solarice products.
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered ↗Class II
Z-0013-2018 · Handicare Usa Inc · posted Sep 15, 2017 · Terminated
During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 lbs). We have identified the root cause as a supplied…
IVEA Product Part Number 16100 Model 500A ↗Class II
Z-3239-2017 · Firefly Medical, Inc. · posted Sep 7, 2017 · Terminated
The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.

Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.