Zimmer Biomet™ 89-8510-421-00Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024355125), received between Feb 10, 2021 and Aug 19, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (2 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.
Most reported problems
Device problems
- Overheating of Device2
- Mechanical Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT A FAILURE OF THE BATTERY CHARGER OCCURRED CAUSING THE BATTERIES TO BECOME WARM DURING CHARGING AND NOT FULLY CHARGE. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME HAS BEEN REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Insufficient Information
MAUDE report 15257180 ↗MalfunctionFeb 10, 2021Mechanical Problem; Overheating of Device; Mechanical Problem; Overheating of Device
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Information
MAUDE report 11306555 ↗
Other Battery, Replacement, Rechargeable devices
- NA 05.001.202Synthes GmbH · BATTERY, REPLACEMENT, RECHARGEABLE263 reports
- Zimmer Biomet™ 89-8521-470-40Zimmer Surgical SA · Battery, Replacement, Rechargeable228 reports
- Zimmer Biomet™ 89-8510-440-10Zimmer Surgical SA · Battery, Replacement, Rechargeable90 reports
- Zimmer Biomet™ 89-8521-470-20Zimmer Surgical SA · Battery, Replacement, Rechargeable34 reports
- NA 05.001.204Synthes GmbH · BATTERY, REPLACEMENT, RECHARGEABLE22 reports
- NA 05.001.231Synthes GmbH · BATTERY, REPLACEMENT, RECHARGEABLE21 reports
- NA 05.001.227Synthes GmbH · BATTERY, REPLACEMENT, RECHARGEABLE11 reports
- Zimmer Biomet™ 89-8510-440-20Zimmer Surgical SA · Battery, Replacement, Rechargeable8 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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