CERTAIN® PREVAIL® IIOS4511Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® PREVAIL® IMPLANT 4/5/4 X 11.5MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868005858), received between Mar 17, 2020 and Apr 2, 2020 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Code Available2
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS FACIALLY & DEHISCENCE. PER INDICATED NO INJURY TO PATIENT. SURGICAL INTERVENTION NECESSARY. PATIENT WILL HAVE TO RETURN TO RETREAT. NO DELAY IN PROCEDURE.
Patient problems: No Code Available
MAUDE report 9918250 ↗InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT REMOVED DUE TO INFECTION.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9841420 ↗
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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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