N/A ZOP30S11Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024021310), received between Aug 24, 2020 and Aug 24, 2020 — classified as 1 injury.
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 Problem1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY CLINICIAN THAT 2.3MM TO 11.5 AND PLACED IMPLANT IN SITE #25 WITH PUROS DBM PUTTY WITH CHIPS. IMPLANT STILL SPUN WITH FINGER PRESSURE AND WAS REMOVED IN SAME PROCEDURE. THE PATIENT WILL NEED TO RETURN FOR NEW IMPLANT PLACEMENT. NO FURTHER INJURY WAS REPORTED. PATIENT HAS A HISTORY OF BRUXISM.
Patient problems: No Information
MAUDE report 10441953 ↗
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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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