OSSEOTITE® 2 XFOS465Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® 2 IMPLANT 4 X 6.5MM · Class 2 · Implant
All models of OSSEOTITE 2 (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868024088), received between Nov 22, 2019 and Mar 18, 2024 — classified as 3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- No Information2
- Osteolysis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 16 AND 36 WERE REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 18921654 ↗InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DOCTOR WAS UNABLE TO PLACE IMPLANT INTO OSTEOTOMY DUE TO A LACK OF PRIMARY STABILITY.
Patient problems: No Information
MAUDE report 9504702 ↗InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED DUE TO LACK OF PRIMARY STABILITY.
Patient problems: No Information
MAUDE report 9364546 ↗
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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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