OSSEOTITE® 2 XFOS310Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® 2 IMPLANT 3.75 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
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00844868023784), received between Jun 10, 2021 and Mar 11, 2025 — classified as 10 injuries.
The most frequently reported specific device problem is “Fracture” (7 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
- Fracture7
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Osteolysis3
- Inflammation2
- Unspecified Infection2
- Abscess1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21570410 ↗InjuryMar 11, 2025Fracture; Fracture
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #36 FAILED BECAUSE IT FRACTURED AT THE HEAD. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21570368 ↗InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE #32. NO IMPACT ON THE PATIENT REPORTED. IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19013008 ↗InjuryJan 4, 2024Fracture; Fracture
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN AN UNKNOWN DENTAL POSITION FAILED BECAUSE IT FRACTURED AT THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: UNKNOWN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18443103 ↗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 12 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 16496590 ↗InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED PERI-IMPLANTITIS WITH INFLAMMATION AND ABSCESS AT TOOTH SITE 8.
Patient problems: Abscess; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 16443780 ↗InjuryJul 1, 2022Fracture; Fracture
IT WAS REPORTED MOBILITY OF CROWN, THE DOCTOR VERIFIED AND FOUND THAT IMPLANT COLLAR WAS FRACTURED, THE REMAINING PART WAS REMOVED. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14884022 ↗InjuryDec 16, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13017311 ↗InjuryDec 10, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Pain; Swelling/ Edema
MAUDE report 12974276 ↗InjuryJun 10, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11977532 ↗
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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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