Zimmer® Universal Power System 89850740010Recalls & reported problems
Zimmer Surgical SA · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024354609), received between Jun 25, 2021 and Sep 29, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Smoking” (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.
Reports received per month
Most reported problems
Device problems
- Smoking2
- Appropriate Device Problem Term/Code Not Available1
- Mechanical Problem1
- Unexpected Shutdown1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2025Smoking; Smoking
IT WAS REPORTED THAT DURING OPERATION MOD ELEC/BATT SGL TRIG HP EMITS A SLIGHT AMOUNT OF SMOKE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23165552 ↗MalfunctionFeb 7, 2025Smoking; Unexpected Shutdown; Smoking; Unexpected Shutdown
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21330462 ↗InjuryJun 25, 2021Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Appropriate Device Problem Term/Code Not Available
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12065771 ↗
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- NA 72201500Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES136 reports
- PLATINUM 72205321Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES118 reports
- Zimmer Biomet™ 89-8509-450-60Zimmer Surgical SA · Saw, Powered, And Accessories83 reports
- NA 72200617Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES77 reports
- NA 72202530Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES53 reports
- DYONICS INCISOR 72203013Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES46 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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