NANOTITECERTAINPREVAILRecalls & reported problems across all models
ZimVie US Corp LLC · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls
- 0
We found 12 models of NANOTITECERTAINPREVAIL by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Sep 18, 2019 and Aug 25, 2025 — classified as 23 injuries.
The most frequently reported specific device problem is “Fracture” (2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported NANOTITECERTAINPREVAIL problems
Device problems
- Adverse Event Without Identified Device or Use Problem21
- Fracture2
Patient problems
- Unspecified Infection15
- No Code Available12
- Inflammation7
- Pain5
- Osteolysis4
- Swelling/ Edema3
- No Information2
- Abscess1
NANOTITECERTAINPREVAIL models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NANOTITE™CERTAIN®PREVAIL® NIIOS4513IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- NANOTITE™CERTAIN®PREVAIL® NIITP4311IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- NANOTITE™CERTAIN®PREVAIL® NIITP5411IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- NANOTITE™CERTAIN®PREVAIL® NIITP6510IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- NANOTITE™CERTAIN®PREVAIL® NIITP4313IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- NANOTITE™CERTAIN®PREVAIL® NIITP5415IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- NANOTITE™CERTAIN®PREVAIL® NIIOS4510IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™CERTAIN®PREVAIL® NIIOS4515IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™CERTAIN®PREVAIL® NIITP5410IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™CERTAIN®PREVAIL® NIITP5485IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™CERTAIN®PREVAIL® NIITP6511IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™CERTAIN®PREVAIL® NIITP6515IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent NANOTITECERTAINPREVAIL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #7, #10 AND #14 WERE REMOVED DUE TO PERI-IMPLANTITIS. NO SYMPTOMS AS A RESULT OF THE EVENT: SWELLING.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 22885595 ↗InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #7, #10 AND #14 WERE REMOVED DUE TO PERI-IMPLANTITIS. NO SYMPTOMS AS A RESULT OF THE EVENT: SWELLING.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 22885441 ↗InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 22865171 ↗InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 FAILED AND WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 19666122 ↗InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 11942770 ↗InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 11941773 ↗InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10957340 ↗InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10957309 ↗InjuryDec 4, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10948622 ↗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 ↗InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 14.
Patient problems: Abscess; Unspecified Infection
MAUDE report 10789400 ↗InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; No Code Available; Unspecified Infection
MAUDE report 10763609 ↗InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS THAT THE NIITP6510 IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS ALSO REPORTED. TOOTH LOCATION #16.
Patient problems: Inflammation; No Code Available; Unspecified Infection
MAUDE report 10726552 ↗InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ALL PATIENTS PERIO MAINTENANCE VISITS AND X-RAYS DEMONSTRATED INCREASE IN POCKET DEPTHS AND ACTIVITY AROUND IMPLANT AT TOOTH LOCATION # 30. IMPLANT AT #30 WAS REMOVED DUE TO SEVER BONE LOSS. NO INJURY TO PATIENT OTHER THAN IMPLANT BEING REMOVED. NO PERMANENT IMPAIRMENT, DOES NOT STATE DELAY OR PATIENT RETURN DATE SYMPTOMS: BONE LOSS.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10579374 ↗InjuryAug 21, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10436036 ↗
Other ZimVie US Corp LLC products
- Tapered Screw-Vent131 models · 13,236 reports · 4 recalls
- OSSEOTITE CERTAIN74 models · 1,891 reports · 1 recall
- TSX Implants28 models · 1,279 reports
- OSSEOTITE73 models · 894 reports
- 3i T3 DCD73 models · 789 reports
- OSSEOTITE CERTAIN PREVAIL15 models · 785 reports
- CERTAIN BELLATEK12 models · 9 reports · 10 recalls
- Eztetic15 models · 382 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page