"1.5MM" SYSTEM 91-6104Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841036053734), received between Mar 8, 2019 and May 29, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 reports).

11 other recalls cover devices cleared under the same FDA submission (K121589, K121624, K953385); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CRANIOTOMY PROCEDURE. DURING THE PROCEDURE, TWO SELF-DRILLING SCREWS FRACTURED AFTER BEING IMPLANTED IN THE CRANIAL REGION. THE FRACTURED DEVICES WERE RETAINED. DUE TO THE EVENT, THERE WAS A SMALL DELAY IN THE PROCEDURE. PATIENT EXPIRED FIVE DAYS POST PROCEDURE. THE PATIENT HAD CANCER AND UNDERWENT A CRANIOTOMY TO REMOVE A TUMOR. THE PATIENT SUFFERED A HEMATOMA THAT WAS NOT RELATED TO THE IMPLANTED PRODUCT AND THE SURGEON STATED THIS IS THE REASON THE PATIENT EXPIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22106225 ↗
• InjuryMay 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CRANIOTOMY PROCEDURE. DURING THE PROCEDURE, TWO SELF-DRILLING SCREWS FRACTURED AFTER BEING IMPLANTED IN THE CRANIAL REGION. THE FRACTURED DEVICES WERE RETAINED. DUE TO THE EVENT, THERE WAS A SMALL DELAY IN THE PROCEDURE. PATIENT EXPIRED FIVE DAYS POST PROCEDURE. THE PATIENT HAD CANCER AND UNDERWENT A CRANIOTOMY TO REMOVE A TUMOR. THE PATIENT SUFFERED A HEMATOMA THAT WAS NOT RELATED TO THE IMPLANTED PRODUCT AND THE SURGEON STATED THIS IS THE REASON THE PATIENT EXPIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22106216 ↗
• MalfunctionFeb 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SCREWS FRAGMENTED DURING IMPLANTATION. THE SURGEON REMOVED THE FRACTURED SCREWS DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578979 ↗
• MalfunctionFeb 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SCREWS FRAGMENTED DURING IMPLANTATION. THE SURGEON REMOVED THE FRACTURED SCREWS DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578948 ↗
• MalfunctionJan 7, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED WHEN THE SURGEON WENT TO IMPLANT THE SCREWS, THE TIP OF THE SCREW DID NOT INSERT CORRECTLY. THE SURGEON CHANGED OUT THE SCREWS AND PROCEEDED WITH THE CASE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192763 ↗
• InjuryAug 16, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12329092 ↗
• InjuryAug 16, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12329083 ↗
• InjuryJul 5, 2019Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN INFORMATION REGARDING THE RETENTION OF THE FOREIGN BODY IN THE PATIENT, AND CONFLICTING INFORMATION WAS RECEIVED. THEREFORE, ZIMMER BIOMET CANNOT DETERMINE AT THIS TIME IF A FOREIGN BODY WAS RETAINED IN THE PATIENT'S BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8765715 ↗
• InjuryMar 8, 2019Device Handling Problem; Device Handling Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 8403796 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121589, K121624, K953385. One submission often covers many models, so check the product and lot details in each record.

• Z-1220-2017 · Jan 10, 2017 · Terminated
  1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
• Z-0136-2016 · Aug 6, 2015 · Terminated
  Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
• Z-0137-2016 · Aug 6, 2015 · Terminated
  Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
• Z-0836-2012 · Nov 8, 2010 · Terminated
  Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE T
• Z-0835-2012 · Nov 8, 2010 · Terminated
  Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS
• Z-2385-2011 · Jul 28, 2010 · Terminated
  ***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***6 HOLE REGULAR DOUBLE Y PLATE***"1.5MM SYSTEM PLATE DOUBL
• Z-2873-2011 · May 17, 2010 · Terminated
  "***REF: 91-6704***THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM (.059X.159") (WXL)***TITANIUM***NON-STERILE PRODUCT***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSON
• Z-1286-2012 · Apr 26, 2010 · Terminated
  Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-L
• Z-2206-2010 · Mar 17, 2010 · Terminated
  BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. BIOMET MICROFIXATION 1520 TRADEPO
• Z-1151-2010 · Oct 6, 2009 · Terminated
  BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MI
• Z-1943-2010 · Oct 5, 2009 · Terminated
  BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***. Bone screws used along with