Zimmer Biomet™ 89-8522-450-60Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024521322), received between Jun 24, 2024 and Jan 9, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (4 reports).
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 Jam4
- Overheating of Device2
- Difficult to Remove1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2025Mechanical Problem; Overheating of Device; Mechanical Jam; Mechanical Problem; Overheating of Device; Mechanical Jam
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21110249 ↗MalfunctionDec 23, 2024Overheating of Device; Difficult to Remove; Mechanical Jam; Overheating of Device; Difficult to Remove; Mechanical Jam
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20999522 ↗MalfunctionAug 6, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE SAW ATTACHMENT STOPS SUDDENLY. THE EVENT OCCURRED OUT OF SURGERY. THERE WAS NO HARM TO THE OPERATOR OR THE PATIENT. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO SERIOUS INJURY. HOWEVER, IN THIS CASE, 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 19916872 ↗MalfunctionJun 24, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT SAGITTAL SAW ATTACHMENT STOPED SUDDENLY DURING THE SURGERY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19592453 ↗
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- NA 530.730Synthes GmbH · MOTOR, SURGICAL INSTRUMENT, AC-POWERED267 reports
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- 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.
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