NANOTITE™CERTAIN®PREVAIL® NIITP6515Recalls & reported problems
ZimVie US Corp LLC · NANOTITE TM TAPERED CERTAIN® PREVAIL® IMPLANT 6/5 X 15MM · Class 2 · Implant
All models of NANOTITECERTAINPREVAIL (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844868011057), received between Nov 20, 2020 and Nov 20, 2020 — classified as 1 injury.
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
Patient problems
- Inflammation1
- No Code Available1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS THAT THE NIITP6515 IMPLANT WAS REMOVED DUE TO BONE LOSS. PAIN AND INFLAMMATION ARE REPORTED AS SYMPTOMS. TOOTH LOCATION # 2. SINUS LIFT HAD BEEN PERFORMED PRIOR TO PLACEMENT IN 2010. GRAFT USED WAS AUTOGENOUS AND XENOGRAFT.
Patient problems: Inflammation; No Code Available; Pain
MAUDE report 10876977 ↗
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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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