OSSEOTITERecalls & reported problems across all models
ZimVie US Corp LLC · 73 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 894
- Deaths reported
- 0
- Injuries reported
- 841
- Recalls
- 0
We found 73 models of OSSEOTITE by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 894 adverse event reports in the FDA's MAUDE database, received between Jun 18, 2019 and Sep 30, 2026 — classified as 841 injuries, 53 malfunctions.
The most frequently reported specific device problem is “Fracture” (192 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 problems
Device problems
- Adverse Event Without Identified Device or Use Problem631
- Fracture192
- Mechanical Problem24
- Separation Failure22
- Loss of Osseointegration13
- Patient-Device Incompatibility11
- Device Damaged by Another Device4
- Detachment of Device or Device Component3
Patient problems
- Unspecified Infection457
- Osteolysis372
- Pain186
- No Clinical Signs, Symptoms or Conditions179
- Inflammation135
- No Information126
- No Code Available74
- Abscess16
OSSEOTITE models
73 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OSSEOTITE® NT411IMPLANT, ENDOSSEOUS, ROOT-FORM68 reports
- OSSEOTITE® NT410IMPLANT, ENDOSSEOUS, ROOT-FORM65 reports
- OSSEOTITE® FNT410IMPLANT, ENDOSSEOUS, ROOT-FORM56 reports
- OSSEOTITE® OSS310IMPLANT, ENDOSSEOUS, ROOT-FORM55 reports
- OSSEOTITE® OSS411IMPLANT, ENDOSSEOUS, ROOT-FORM55 reports
- OSSEOTITE® FNT411IMPLANT, ENDOSSEOUS, ROOT-FORM54 reports
- OSSEOTITE® OSS311IMPLANT, ENDOSSEOUS, ROOT-FORM52 reports
- OSSEOTITE® OSS410IMPLANT, ENDOSSEOUS, ROOT-FORM41 reports
- OSSEOTITE® NT413IMPLANT, ENDOSSEOUS, ROOT-FORM29 reports
- OSSEOTITE® NT485IMPLANT, ENDOSSEOUS, ROOT-FORM28 reports
- OSSEOTITE® FNT485IMPLANT, ENDOSSEOUS, ROOT-FORM25 reports
- OSSEOTITE® OSS413IMPLANT, ENDOSSEOUS, ROOT-FORM25 reports
- OSSEOTITE® OSS313IMPLANT, ENDOSSEOUS, ROOT-FORM22 reports
- OSSEOTITE® FNT413IMPLANT, ENDOSSEOUS, ROOT-FORM19 reports
- OSSEOTITE® NT510IMPLANT, ENDOSSEOUS, ROOT-FORM18 reports
- OSSEOTITE® NT585IMPLANT, ENDOSSEOUS, ROOT-FORM18 reports
- OSSEOTITE® FNT510IMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- OSSEOTITE® FNT585IMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- OSSEOTITE® FNT3210IMPLANT, ENDOSSEOUS, ROOT-FORM15 reports
- OSSEOTITE® NT511IMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- OSSEOTITE® FNT3211IMPLANT, ENDOSSEOUS, ROOT-FORM13 reports
- OSSEOTITE® NT3211IMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
- OSSEOTITE® OSS385IMPLANT, ENDOSSEOUS, ROOT-FORM11 reports
- OSSEOTITE® FOS411IMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- OSSEOTITE® OSS510IMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- OSSEOTITE® NT3210IMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- OSSEOTITE® OSS415IMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- OSSEOTITE® FOS413IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- OSSEOTITE® NT3285IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- OSSEOTITE® FNT511IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- OSSEOTITE® FOS410IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- OSSEOTITE® OSS585IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- OSSEOTITE® FOS310IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- OSSEOTITE® FOS311IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- OSSEOTITE® FOS507IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- OSSEOTITE® FOS511IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- OSSEOTITE® NT3213IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- OSSEOTITE® NT415IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- OSSEOTITE® NT513IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- OSSEOTITE® OSM311IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- OSSEOTITE® OSM313IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- OSSEOTITE® OSS315IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- OSSEOTITE® OSS320IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- OSSEOTITE® FNT3213IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- OSSEOTITE® FOS415IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- OSSEOTITE® OSS485IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- OSSEOTITE® OSS511IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- OSSEOTITE® OSS515IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- OSSEOTITE® FNT415IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- OSSEOTITE® FNT513IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- OSSEOTITE® FOS307IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- OSSEOTITE® FOS313IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- OSSEOTITE® FOS385IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- OSSEOTITE® FOS407IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- OSSEOTITE® FOS485IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- OSSEOTITE® FOS510IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- OSSEOTITE® FOSM310IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- OSSEOTITE® NT515IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- OSSEOTITE® OSS420IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- OSSEOTITE® OSS513IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- OSSEOTITE® FNT3285IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® FNT685IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® FOS513IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® FOS685IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® FOSM307IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® NT3215IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® NT610IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® NT685IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® OSM310IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® OSM315IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® OSS507IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® OSS611IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- OSSEOTITE® OSS685IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent OSSEOTITE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fracture; Loss of Osseointegration
The doctor reports that the dental implants failed because they fractured by the head & body. Loss of integration was also reported. Tooth sites 24 and 25.The doctor reports that the procedure was not concluded by placing another implants.Bone type: III.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946394 ↗InjurySep 30, 2026Fracture; Loss of Osseointegration
The doctor reports that the dental implants failed because they fractured by the head & body. Loss of integration was also reported. Tooth sites 24 and 25.The doctor reports that the procedure was not concluded by placing another implants.Bone type: III.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946335 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to a peri-implantitis at tooth site 16.Abscess, pain and inflammation were reported as a consequence.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 50914636 ↗InjurySep 18, 2026Fracture
The doctor reports that the dental implant failed because it fractured at the body. Tooth site 35.The doctor reports that the procedure was concluded by placing another implant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816977 ↗InjurySep 18, 2026Fracture
The doctor reports that the dental implant failed because it fractured at the body. Tooth site 35.The doctor reports that the procedure was not concluded by placing another implant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816913 ↗InjuryJul 31, 2026Separation Failure
It was reported the mount won't come off. The mount was too tight to remove. Tooth site # 28. Implant was removed. Procedure not completed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50096375 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported a Periimplantitis at tooth site #36. Implant was removed. Bone Type: III.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50081335 ↗InjuryJul 28, 2026Patient-Device Incompatibility
The doctor reports that the dental implant failed due to Allergic reactoin.The doctor reports in the PER that the procedure was concluded..
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 50054352 ↗InjuryJul 28, 2026Fracture
The doctor reports that the dental implant failed because it fractured by the body.Only the upper portion of the implant, including the implant head, was returned.The fractured fragment of the implant body was not returned.The doctor reports that the procedure was not concluded by placing another implant. Tooth site 27.Bone type: II.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50053827 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
The doctor reports that the dental implant failed due to peri-implantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50052081 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #24 AND #25 WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25449304 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #24 AND #25 WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25449264 ↗InjuryMay 29, 2026Fracture
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER 36 FAILED BECAUSE IT FRACTURED AT THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25328286 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO BONE LOSS AND PERI-IMPLANTITIS. THE PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25284232 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO BONE LOSS AND PERI-IMPLANTITIS THE PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25284135 ↗
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
- 3i T3 DCD73 models · 789 reports
- OSSEOTITE CERTAIN PREVAIL15 models · 785 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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