OSSEOTITE® CERTAIN® 2 XIFOSS611Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® CERTAIN® 2 IMPLANT 6 X 11.5MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN 2 (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844868023272), received between May 21, 2019 and May 21, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Mechanical Problem1
- Separation Failure1
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.
MalfunctionMay 21, 2019Mechanical Problem; Separation Failure; Mechanical Problem; Separation Failure
IT WAS REPORTED THAT THE IMPLANT GOT STUCK AT TOOTH LOCATION #19. THE IMPLANT DID NOT SEAT ALL THE WAY. THE IMPLANT WAS DAMAGED WHILE TRYING TO REMOVE IT AND SOME BONE WAS REMOVED. THE SITE WAS GRAFTED AND BUCCAL BONE REMOVED. THE PROCEDURE WAS COMPLETED DURING THE SAME PROCEDURE. THE SECOND IMPLANT PLACEMENT WAS SUCCESSFUL.
Patient problems: No Information
MAUDE report 8628771 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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