OSSEOTITE® FOS310Recalls & reported problems
ZimVie US Corp LLC · FULL OSSEOTITE® IMPLANT 3.75 X 10MM · Class 2 · Implant
All models of OSSEOTITE (73)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868003489), received between Dec 10, 2019 and Jun 19, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Unspecified Infection3
- No Information2
- Inflammation1
- No Code Available1
- Osteolysis1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #24 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19566317 ↗InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 19 WAS REMOVED DUE TO INFECTION. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 13025837 ↗InjuryJan 4, 2021Fracture; Fracture
IT WAS REPORTED IMPLANT FRACTURED. DOCTOR REMOVED THE FRACTURED PORTIONS FROM PATIENT´S MOUTH AND DID A BONE GRAFT. DOCTOR WILL WAIT FOR HEALING TO PLACE ANOTHER IMPLANT.
Patient problems: No Information
MAUDE report 11108314 ↗InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVALIABLE AT THE TIME OF THIS REPORT.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9449930 ↗InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT FRACTURED ONE YEAR AFTER LOADING. IMPLANT WAS REMOVED.
Patient problems: No Information
MAUDE report 9443172 ↗
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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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