OSSEOTITE® 2 XFOSM311Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® 2 IMPLANT 3.25 X 11.5MM · Class 2 · Implant
All models of OSSEOTITE 2 (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868024033), received between Apr 15, 2020 and Sep 25, 2024 — classified as 4 injuries, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Mechanical Problem1
Patient problems
- Unspecified Infection4
- Osteolysis3
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED THAT THE IMPLANT AT TOOTH SITE #31 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20299404 ↗InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION 21 WAS REMOVED DUE TO BONE LOSS AND INFECTION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16496564 ↗MalfunctionJun 3, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT FAILED DUE TO A MALFUNCTION IN THE HEXAGON. THE DOCTOR REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT ON THE SAME DAY AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14587987 ↗InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 13948526 ↗InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9961875 ↗
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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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