OSSEOTITE 2Recalls & reported problems across all models

We found 20 models of OSSEOTITE 2 by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 62 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2019 and Jul 19, 2025 — classified as 57 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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

Most reported OSSEOTITE 2 problems

OSSEOTITE 2 models

20 models, most reported first. Each model has its own page with its reports, recalls and device details.

• OSSEOTITE® 2 XFOS310

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  10 reports
• OSSEOTITE® 2 XFOS411

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  7 reports
• OSSEOTITE® 2 XFOS311

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  6 reports
• OSSEOTITE® 2 XFOS410

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  5 reports
• OSSEOTITE® 2 XFOSM311

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  5 reports
• OSSEOTITE® 2 XFOSM385

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  4 reports
• OSSEOTITE® 2 XFOS510

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  3 reports
• OSSEOTITE® 2 XFOS465

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  3 reports
• OSSEOTITE® 2 XFOS565

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  3 reports
• OSSEOTITE® 2 XFOS485

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  2 reports
• OSSEOTITE® 2 XFOS585

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  2 reports
• OSSEOTITE® 2 XFOSM310

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  2 reports
• OSSEOTITE® 2 XFOS665

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  2 reports
• OSSEOTITE® 2 XFOSM365

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  2 reports
• OSSEOTITE® 2 XFOS313

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• OSSEOTITE® 2 XFOS385

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• OSSEOTITE® 2 XFOS511

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• OSSEOTITE® 2 XFOS610

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• OSSEOTITE® 2 XFOS685

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• OSSEOTITE® 2 XFOS365

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report

Recent OSSEOTITE 2 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITES #14, #15.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22550231 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE 15 OBSERVED DURING THE CLINICAL PROCEDURE. PLACEMENT OF RIGHT UPPER MAX IMPLANT AT TOOTH SITE 15 WITH USUAL FLAP AND SUTURING. WITHDRAWAL OF STITCHES 11 DAYS LATER. ON (B)(6), PATIENT WENT TO CLINIC DUE TO INFLAMMATION AND ABSCESS; PERI-IMPLANTITIS AND IMPLANT MOBILITY WAS DETECTED AND IMPLANT WAS REMOVED. THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22165466 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A BONE LOSS AT TOOTH SITE #44. IMPLANT WAS REMOVED. PAIN WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 21631522 ↗
• InjuryMar 11, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21570410 ↗
• InjuryMar 11, 2025Fracture; Fracture

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #36 FAILED BECAUSE IT FRACTURED AT THE HEAD. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21570368 ↗
• MalfunctionFeb 6, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT IMPLANT COULD NOT BE RELEASE FROM THE MOUNT. AFTER FOLLOW UP, PROCEEDING WAS COMPLETED WITH ANOTHER IMPLANT. TOOTH LOCATION 46.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319938 ↗
• InjuryJan 13, 2025Adverse 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 PERI-IMPLANTITIS. PAIN REPORTED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21136108 ↗
• InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE IMPLANT HAD TO BE REMOVED DUE TO NERVE DAMAGE. PROCEDURE NOT COMPLETED.

  Patient problems: Nerve Damage

  MAUDE report 20999702 ↗
• InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE IMPLANTS HAD TO BE REMOVED DUE TO NERVE DAMAGE. PROCEDURE NOT COMPLETED.

  Patient problems: Nerve Damage

  MAUDE report 20998845 ↗
• InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE IMPLANTS HAD TO BE REMOVED DUE TO NERVE DAMAGE. PROCEDURE NOT COMPLETED.

  Patient problems: Nerve Damage

  MAUDE report 20998779 ↗
• InjuryDec 11, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 20902379 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #16. IMPLANT WAS COMPLETELY REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20308764 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #25. IMPLANT WAS COMPLETELY REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20308524 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANT AT TOOTH SITE #31 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20299404 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 19741651 ↗

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