Zimmer Biomet™ 89-8522-451-43Recalls & reported problems
Zimmer Surgical SA · Class 1
All models of Zimmer Biomet (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024521346), received between Apr 26, 2024 and Apr 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE LOCKING MECHANISM WAS LOOSE AND FAILED TO HOLD THE PIN. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19191190 ↗
Other Motor, Surgical Instrument, Ac-Powered devices
- NA 05.001.201Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED1,902 reports
- NA 530.710Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED1,800 reports
- NA 530.705Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED1,492 reports
- NA 530.715Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED390 reports
- NA 530.730Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED267 reports
- NA 05.001.240Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED262 reports
- KINCISE™ 1000-00-101Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED242 reports
- NA 530.791Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED84 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page