OSSEOTITE® FOS410Recalls & reported problems
ZimVie US Corp LLC · FULL OSSEOTITE® IMPLANT 4 X 10MM · Class 2 · Implant
All models of OSSEOTITE (73)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844868003601), received between Dec 18, 2019 and Jul 28, 2026 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Adverse Event Without Identified Device or Use Problem2
- Separation Failure1
Patient problems
- No Information3
- No Clinical Signs, Symptoms or Conditions2
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2026Fracture
The doctor reports that the dental implant failed because it fractured by the body.Only the upper portion of the implant, including the implant head, was returned.The fractured fragment of the implant body was not returned.The doctor reports that the procedure was not concluded by placing another implant. Tooth site 27.Bone type: II.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50053827 ↗InjuryApr 11, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 36 FRACTURED AT THE BODY OF THE IMPLANT AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19087684 ↗InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 LACKED PRIMARY STABILITY WHEN PLACING AND WERE REMOVED, PROCEDURE WAS NOT COMPLETED BY PLACING ANTHER IMPLANT.
Patient problems: No Information
MAUDE report 11088462 ↗InjuryAug 7, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10377616 ↗InjuryApr 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PROGRESSIVE PERI-IMPLANTITIS AND INFLAMMATION ON TOOTH LOCATION 45. PERI-IMPLANTITIS HAS BEEN TREATED INITIALLY ON A TRADITIONAL WAY. DOCTOR PERFORMED FLAP SURGERY AND REMOVED INFLAMMED TISSUE. PATIENT HAS BEEN RESCHEDULED FOR BONE GRAFT PLACEMENT.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9932303 ↗MalfunctionDec 18, 2019Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 9487249 ↗
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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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