OSSEOTITE® 2 XFOS410Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® 2 IMPLANT 4 X 10MM · Class 2 · Implant
All models of OSSEOTITE 2 (20)
Data updated Oct 16, 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 00844868023845), received between Aug 18, 2021 and Jul 19, 2025 — classified as 5 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 Problem5
Patient problems
- Osteolysis4
- Unspecified Infection4
- Abscess1
- Inflammation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITES #14, #15.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22550231 ↗InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #16. IMPLANT WAS COMPLETELY REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20308764 ↗InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT REMOVED DUE TO INFECTION. PURULENT LIQUID. TOOTH LOCATION 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18371667 ↗InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANT AT AN UNKNOWN TOOTH SITE WAS REMOVED DUE TO PERI-IMPLANTITIS. THE TOOTH SITE PRESENTED ABSCESS AND INFLAMMATION.
Patient problems: Abscess; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 12790403 ↗InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 29 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 12335782 ↗
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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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