OSSEOTITE CERTAIN PREVAILRecalls & 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
- 785
- Deaths reported
- 0
- Injuries reported
- 754
- Recalls
- 0
We found 15 models of OSSEOTITE CERTAIN PREVAIL by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 785 adverse event reports in the FDA's MAUDE database, received between Jun 10, 2019 and Sep 28, 2026 — classified as 754 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (44 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 PREVAIL problems
Device problems
- Adverse Event Without Identified Device or Use Problem715
- Mechanical Problem44
- Fracture8
- Patient-Device Incompatibility5
- Failure to Osseointegrate4
- Loss of Osseointegration4
- Separation Failure4
- Insufficient Device Problem Information2
Patient problems
- Unspecified Infection442
- Osteolysis358
- Pain175
- No Clinical Signs, Symptoms or Conditions86
- Inflammation85
- No Information49
- No Code Available44
- Abscess41
OSSEOTITE CERTAIN PREVAIL models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OSSEOTITE® CERTAIN® PREVAIL XIITP4311IMPLANT, ENDOSSEOUS, ROOT-FORM142 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP5410IMPLANT, ENDOSSEOUS, ROOT-FORM94 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP4313IMPLANT, ENDOSSEOUS, ROOT-FORM89 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP4310IMPLANT, ENDOSSEOUS, ROOT-FORM71 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP5485IMPLANT, ENDOSSEOUS, ROOT-FORM61 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP5411IMPLANT, ENDOSSEOUS, ROOT-FORM57 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP6510IMPLANT, ENDOSSEOUS, ROOT-FORM54 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP6511IMPLANT, ENDOSSEOUS, ROOT-FORM50 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP5413IMPLANT, ENDOSSEOUS, ROOT-FORM47 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP4385IMPLANT, ENDOSSEOUS, ROOT-FORM27 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP4315IMPLANT, ENDOSSEOUS, ROOT-FORM27 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP6513IMPLANT, ENDOSSEOUS, ROOT-FORM22 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP6585IMPLANT, ENDOSSEOUS, ROOT-FORM22 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP5415IMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
- OSSEOTITE® CERTAIN® PREVAIL XIITP6515IMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
Recent OSSEOTITE CERTAIN PREVAIL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported the implant at tooth site 21 was removed due to peri-implantitis. When switching cover screw for and encode healing abutment, infection was noticed and implant was loose. Patient had previous infection on the site which it was clean and treated but due to patient medical condition with low platelets counts, the infection came back and 2 implants had to be removed.This event refers to the peri-implantitis in tooth site 21.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50913977 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site #7 was removed due to peri-implantitis with loss of osseointegration. The patient experienced pain, edema, and inflammation.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50768302 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50650946 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implants at tooth sites 22 (XIITP4313) and 23 (XIFNT513) were removed due to periimplantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50066710 ↗InjuryJul 28, 2026Device Damaged by Another Device
It was reported that the implant was internally stripped and was removed. Tooth site 30.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054791 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth #4 was removed due to bone loss during the patient¿s conversion to a maxillary DIEM.
Patient problems: Osteolysis
MAUDE report 50035195 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. BUCCAL BONE GRAFTING DID NOT ADHERE TO LOSS OF BONE AROUND IMPLANT #29 (4.3 X 8.5). REMOVED IMPLANT AND PLACED NEW 4/3 X 8.5MM IMPLANT.
Patient problems: Osteolysis
MAUDE report 25478103 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME BACK TO THE CLINIC DUE TO GUM RECESSION AND THREADS OF THE IMPLANTS SHOWING. THE IMPLANTS AT TOOTH SITES #6 AND #7 HAD SEVERE BONE LOSS AND WERE REMOVED. BONE GRAFT WAS PLACED.
Patient problems: Osteolysis
MAUDE report 25476960 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT RETURNED REGARDING SEVERE BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #31. THE DENTIST WAS NOT COMFORTABLE RESTORING THE IMPLANT WITH SUCH BONE LOSS. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED.
Patient problems: Osteolysis
MAUDE report 25476691 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 4 WAS REMOVED DUE TO INFECTION & BONE LOSS. IMPLANT PLACE (B)(6) 2026 SUTURE REMOVAL (B)(6) 2026 PATIENT RETURNED ON 5/20/26 WITH PAIN AND EXAM REVEALED GINGIVAL SWELLING. IMPLANT WAS UNCOVERED AND NOTED TO HAVE BONE LOSS AND WAS LOOSE. IMPLANT WAS REMOVED AND OSTEOTOMY DEBRIDED. SYMPTOMS / PATIENT IMPACT: EDEMA, INFLAMMATION, SWELLING.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25473872 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TWO (2) IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PATIENT WILL RETURN TO HAVE IMPLANTS REPLACED. TOOTH LOCATIONS WERE NOT PROVIDED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25399467 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TWO (2) IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PATIENT WILL RETURN TO HAVE IMPLANTS REPLACED. TOOTH LOCATIONS WERE NOT PROVIDED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25399370 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME TO THE CLINIC WITH SWELLING AND PAIN AT THE MANDIBULAR RIGHT SIDE. THE IMPLANT AT TOOTH SITE #29 WAS INFECTED. THE IMPLANT WAS REMOVED AND INCISION WITH DRAINAGE WAS PERFORMED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 25284240 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #2 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT FELL OUT AT DENTIST DURING CROWN SEATING.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25281073 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO INFECTION. THE IMPLANT HAD BEEN PLACED IN 2022 WITH NO PARTICULAR PROBLEMS AND GOOD STABILITY. THE PATIENT RETURNED IN THE SUMMER OF 2025 WITH AN ABSCESS ON THE IMPLANT, ACCOMPANIED BY SUPPURATION AND MARKED MOBILITY. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 25233398 ↗
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
- CERTAIN BELLATEK12 models · 9 reports · 10 recalls
- Eztetic15 models · 382 reports
- Tapered SwissPlus12 models · 376 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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