NANOTITE CERTAINRecalls & reported problems across all models
ZimVie US Corp LLC · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls
- 0
We found 15 models of NANOTITE CERTAIN by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Sep 17, 2019 and Mar 2, 2026 — classified as 28 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 NANOTITE CERTAIN problems
Device problems
- Adverse Event Without Identified Device or Use Problem24
- Fracture2
- Mechanical Problem1
- Unintended Movement1
Patient problems
- Unspecified Infection22
- No Code Available12
- Inflammation10
- Pain6
- Osteolysis5
- Edema4
- No Information3
- Abscess2
NANOTITE CERTAIN models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NANOTITE™ CERTAIN® NINT410IMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- NANOTITE™ CERTAIN® NINT585IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- NANOTITE™ CERTAIN® NINT411IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- NANOTITE™ CERTAIN® NINT510IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- NANOTITE™ CERTAIN® NIOSS413IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- NANOTITE™ CERTAIN® NINT3211IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™ CERTAIN® NINT3213IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™ CERTAIN® NINT3215IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™ CERTAIN® NINT3285IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™ CERTAIN® NINT413IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™ CERTAIN® NINT511IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™ CERTAIN® NINT610IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™ CERTAIN® NINT611IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™ CERTAIN® NIOSS510IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- NANOTITE™ CERTAIN® NIOSS513IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent NANOTITE CERTAIN adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 2, 2026Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24490098 ↗InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. AFTER REMOVAL, THE EXTRACTION SITE WAS GRAFTED WITH BONE GRAFT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18833300 ↗InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18116853 ↗InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PUS AND SORENESS. TOOTH LOCATION IS UNKNOWN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 17603634 ↗InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 12682412 ↗InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH LOCATION 23. SWELLING AND INFLAMMATION WERE ALSO REPORTED.
Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection
MAUDE report 12220944 ↗InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR INDICATED INFECTION. THE MUCOSA AROUND THE IMPLANT AT TOOTH SITE #21 WAS RED AND SWOLLEN, LEADING TO THE IMPLANT FAILURE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 12211293 ↗InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD PERI-IMPLANTITIS WITH INFECTION, LOSS OF INTEGRATION, AN ABSCESS, PAIN AND EDEMA PRESENT. IMPLANT WAS REMOVED AND PATIENT WILL RETURN FOR A REPLACEMENT IMPLANT IN THE FUTURE. TOOTH #19.
Patient problems: Abscess; Inadequate Osseointegration; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 11337805 ↗InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS THAT THE NINT410 IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. TOOTH LOCATION # 29. THE SITE WAS GRAFTED WITH XENOGRAFT PRIOR TO ORIGINAL PLACEMENT. PAIN IS ALSO REPORTED.
Patient problems: No Code Available; Pain; Unspecified Infection
MAUDE report 11193929 ↗InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED PERI-IMPLANTITIS AFTER THE IMPLANTATION. PATENT PRESENTED WITH INFLAMMATION AND EDEMA.
Patient problems: Edema; No Code Available; Unspecified Infection
MAUDE report 11138918 ↗InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE IMPLANT HAD TO BE REMOVED DUE TO PERI-IMPLANTITIS, INFLAMMATION, EDEMA AND A LOSS OF INTEGRATION. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS.
Patient problems: Edema; Inflammation; No Code Available; Unspecified Infection
MAUDE report 11127160 ↗InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AT TOOTH LOCATION 9. INFLAMMATION AND EDEMA WAS ALSO REPORTED.
Patient problems: Edema; Inflammation; Unspecified Infection
MAUDE report 11127086 ↗InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS AROUND IMPLANT.
Patient problems: No Code Available
MAUDE report 11119212 ↗InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 WAS REMOVED DUE TO BONE LOSS AROUND IMPLANT.
Patient problems: No Code Available
MAUDE report 11118427 ↗InjuryNov 11, 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: Abscess; Pain; Unspecified Infection
MAUDE report 10824254 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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