OSSEOTITE CERTAIN 2Recalls & reported problems across all models
ZimVie US Corp LLC · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 138
- Deaths reported
- 0
- Injuries reported
- 133
- Recalls
- 0
We found 19 models of OSSEOTITE CERTAIN 2 by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 138 adverse event reports in the FDA's MAUDE database, received between May 21, 2019 and Jul 27, 2026 — classified as 133 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (18 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 OSSEOTITE CERTAIN 2 problems
Device problems
- Adverse Event Without Identified Device or Use Problem112
- Fracture18
- Mechanical Problem7
- Failure to Osseointegrate1
- Loss of Osseointegration1
- Patient-Device Incompatibility1
- Separation Failure1
Patient problems
- Unspecified Infection66
- Osteolysis55
- Pain45
- Inflammation18
- No Clinical Signs, Symptoms or Conditions18
- Abscess9
- No Information9
- Swelling/ Edema5
OSSEOTITE CERTAIN 2 models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OSSEOTITE® CERTAIN® 2 XIFOSS411IMPLANT, ENDOSSEOUS, ROOT-FORM30 reports
- OSSEOTITE® CERTAIN® 2 XIFOSS410IMPLANT, ENDOSSEOUS, ROOT-FORM23 reports
- OSSEOTITE® CERTAIN® 2 XIFOSS413IMPLANT, ENDOSSEOUS, ROOT-FORM20 reports
- OSSEOTITE® CERTAIN® 2 XIFOSM311IMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
- OSSEOTITE® CERTAIN® 2 XIFOSM310IMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- OSSEOTITE® CERTAIN® 2 XIFOSS485IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- OSSEOTITE® CERTAIN® 2 XIFOSS510IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- OSSEOTITE® CERTAIN® 2 XIFOSS585IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- OSSEOTITE® CERTAIN® 2 XIFOSS415IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- OSSEOTITE® CERTAIN® 2 XIFOSM313IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- OSSEOTITE® CERTAIN® 2 XIFOSM385IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- OSSEOTITE® CERTAIN® 2 XIFOSS610IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- OSSEOTITE® CERTAIN® 2 XIFOSS685IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- OSSEOTITE® CERTAIN® 2 XIFOSS515IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- OSSEOTITE® CERTAIN® 2 XIFOSM315IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® CERTAIN® 2 XIFOSS511IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® CERTAIN® 2 XIFOSS513IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® CERTAIN® 2 XIFOSS611IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® CERTAIN® 2 XIFOSS615IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent OSSEOTITE CERTAIN 2 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth #30 was removed due to bone loss.
Patient problems: Osteolysis
MAUDE report 50033246 ↗InjuryJun 8, 2026Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS STRIPPED WHERE THE HEX DRIVER GOES IN. THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25430193 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25220158 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THREE (3) YEARS POST-OP, THE PATIENT PRESENTED WITH BONE LOSS AROUND THE IMPLANT AT TOOTH SITE # (B)(6). THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 25170961 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS MOBILE AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25159607 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS MOBILE AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ASPIRATION, PARESTHESIA AND EDEMA.
Patient problems: Aspiration/Inhalation; Osteolysis; Unspecified Infection
MAUDE report 25159521 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #35 WAS MOBILE AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND PURULENCE.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25135576 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO BONE LOSS. IMPLANT FOUND TO BE MOBILE WHILE PERFORMING UNCOVERING PROCEDURE. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT.
Patient problems: Osteolysis
MAUDE report 24619634 ↗InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteomyelitis; Unspecified Infection
MAUDE report 24404866 ↗InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO BONE LOSS AND COMPLAINTS OF PAIN. THE PAIN WAS RESOLVED UPON REMOVAL.
Patient problems: Osteolysis; Pain
MAUDE report 24162722 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #25 WAS REMOVED DUE TO PERI-IMPLANTITIS. BONE REGENERATION WAS PERFORMED. ANOTHER IMPLANT WILL BE PLACED LATER.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24084469 ↗InjuryJan 14, 2026Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 24065825 ↗InjuryNov 10, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23508180 ↗InjuryNov 10, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23508089 ↗InjuryNov 6, 2025Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 23485895 ↗
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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