OSSEOTITE® 2 XFOS585Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® 2 IMPLANT 5 X 8.5MM · Class 2 · Implant
All models of OSSEOTITE 2 (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868023944), received between Jul 7, 2022 and Dec 23, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Separation Failure1
Patient problems
- Nerve Damage1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE IMPLANT HAD TO BE REMOVED DUE TO NERVE DAMAGE. PROCEDURE NOT COMPLETED.
Patient problems: Nerve Damage
MAUDE report 20999702 ↗MalfunctionJul 7, 2022Separation Failure; Separation Failure
DOCTOR REPORTED THAT AFTER INSERTION OF THE IMPLANT AT TOOTH SITE 26, THE MOUNT COULD NOT BE DISENGAGED FROM THE IMPLANT. MANUAL TOOLS WERE USED, BUT IN THE END IT WAS NECESSARY TO REMOVE THE IMPLANT AND PLACE ANOTHER ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14950294 ↗
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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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