Medical device recalls: December 2020

The FDA posted 41 medical device recall records in December 2020, from 6 recall events by 6 companies. 21 are 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

Cook Inc. · 1 event, 21 records, 21 Class I
Biomet, Inc. · 1 event, 16 records
Galt Medical Corporation · 1 event, 1 record
GE Healthcare, LLC · 1 event, 1 record
Remote Diagnostic Technologies Ltd. · 1 event, 1 record
ROi CPS LLC · 1 event, 1 record

FDA root cause

Process control · 38
Use error · 1
Software design · 1
Labeling Change Control · 1

Class I recalls (21)

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

Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 ↗Class I
Z-0591-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 ↗Class I
Z-0592-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 ↗Class I
Z-0593-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 ↗Class I
Z-0594-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 ↗Class I
Z-0595-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 ↗Class I
Z-0596-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 ↗Class I
Z-0597-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 ↗Class I
Z-0598-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 ↗Class I
Z-0599-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 ↗Class I
Z-0600-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 ↗Class I
Z-0601-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 ↗Class I
Z-0602-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 ↗Class I
Z-0603-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 ↗Class I
Z-0604-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 ↗Class I
Z-0605-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 ↗Class I
Z-0606-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 ↗Class I
Z-0607-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 ↗Class I
Z-0608-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 ↗Class I
Z-0609-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 ↗Class I
Z-0610-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 ↗Class I
Z-0611-2021 · Cook Inc. · posted Dec 23, 2020 · Terminated
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited…

Class II recalls (20)

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

3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 ↗Class II
Z-0616-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, ↗Class II
Z-0617-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, ↗Class II
Z-0618-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552,Class II
Z-0619-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical… ↗Class II
Z-0620-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Custom Cancellous Thread, Item numbers CP161941,Class II
Z-0621-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures.Class II
Z-0622-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.Class II
Z-0623-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Oxford Fixed Lateral, Item numbers 154330, 154370, 154373Class II
Z-0624-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage:…Class II
Z-0625-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
RapidFire Clip, Item Number 95-0154 - Product Usage: ↗Class II
Z-0626-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage:…Class II
Z-0627-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip,…Class II
Z-0628-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial boneClass II
Z-0629-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation. ↗Class II
Z-0630-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, ↗Class II
Z-0631-2021 · Biomet, Inc. · posted Dec 17, 2020 · Terminated
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 ↗Class II
Z-0568-2021 · Galt Medical Corporation · posted Dec 14, 2020 · Terminated
Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
Tempus LS - Manual Defibrillator, Model Number: 00-3020Class II
Z-0564-2021 · Remote Diagnostic Technologies Ltd. · posted Dec 11, 2020 · Terminated
A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in therapy, as the…
MAC VU360, ElectrocardiographClass II
Z-0543-2021 · GE Healthcare, LLC · posted Dec 7, 2020 · Terminated
Incorrect patient identification and/or patient demographic errors.
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits. ↗Class II
Z-0524-2021 · ROi CPS LLC · posted Dec 2, 2020 · Terminated
Labeling error, incorrect expiration date.

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.