OSSEOTITE® FOS507Recalls & reported problems
ZimVie US Corp LLC · FULL OSSEOTITE® IMPLANT 5 X 7MM · Class 2 · Implant
All models of OSSEOTITE (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868003717), received between Jan 31, 2020 and Jul 24, 2025 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (2 reports).
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
- Separation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Unspecified Infection2
- Osteolysis1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2025Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22584977 ↗MalfunctionJul 24, 2025Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22584943 ↗InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE # 46. PATIENT WENT TO THE DENTIST'S OFFICE WITH THE IMPLANT IN HAND.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20397693 ↗InjuryJun 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT AT TOOTH SITE # 29 WAS REMOVED DUE TO LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12072440 ↗InjuryJan 31, 2020Adverse 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 INFECTION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 9655593 ↗
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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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