OSSEOTITE® CERTAIN® 2 XIFOSS515Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® CERTAIN® 2 IMPLANT 5 X 15MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN 2 (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868023241), received between Apr 1, 2021 and Sep 13, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Mechanical Problem1
Patient problems
- Abscess1
- Inflammation1
- Insufficient Information1
- Osteolysis1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED PERI-IMPLANTITIS WITH SIGNIFICANT BONE LOSS AT THE IMPLANT AT TOOTH LOCATION #6. SYMPTOMS AS A RESULT OF THE EVENT: LOSS OF INTEGRATION, ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Abscess; Inflammation; Osteolysis; Pain; Unspecified Infection
MAUDE report 15411691 ↗MalfunctionApr 1, 2021Mechanical Problem; Mechanical Problem
THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.
Patient problems: Insufficient Information
MAUDE report 11604321 ↗
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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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