OSSEOTITE CERTAINRecalls & reported problems across all models

We found 74 models of OSSEOTITE CERTAIN by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 1,891 adverse event reports in the FDA's MAUDE database, received between May 1, 2019 and Sep 30, 2026 — classified as 1,846 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Fracture” (73 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

OSSEOTITE CERTAIN recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 8, 2016Terminated

   Product was incorrectly packaged.

   Z-2845-2016 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported OSSEOTITE CERTAIN problems

OSSEOTITE CERTAIN models

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

• OSSEOTITE® CERTAIN® XIFNT410

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  194 reports
• OSSEOTITE® CERTAIN® XIFNT411

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  140 reports
• OSSEOTITE® CERTAIN® XIFNT3211

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  113 reports
• OSSEOTITE® CERTAIN® XIFNT3210

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  97 reports
• OSSEOTITE® CERTAIN® XIFNT510

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  88 reports
• OSSEOTITE® CERTAIN® INT410

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  87 reports
• OSSEOTITE® CERTAIN® XIFNT485

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  73 reports
• OSSEOTITE® CERTAIN® XIFNT3213

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  72 reports
• OSSEOTITE® CERTAIN® IOSS411

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 recall16 reports
• OSSEOTITE® CERTAIN® XIFNT413

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  59 reports
• OSSEOTITE® CERTAIN® INT411

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  58 reports
• OSSEOTITE® CERTAIN® XIFNT511

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  58 reports
• OSSEOTITE® CERTAIN® XIFNT585

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  55 reports
• OSSEOTITE® CERTAIN® XIFNT3285

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  37 reports
• OSSEOTITE® CERTAIN® IFNT410

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  35 reports
• OSSEOTITE® CERTAIN® INT3211

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  35 reports
• OSSEOTITE® CERTAIN® INT510

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  35 reports
• OSSEOTITE® CERTAIN® INT485

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  34 reports
• OSSEOTITE® CERTAIN® IFNT510

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  30 reports
• OSSEOTITE® CERTAIN® INT3210

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  28 reports
• OSSEOTITE® CERTAIN® XIFNT3215

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  27 reports
• OSSEOTITE® CERTAIN® IFNT585

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  26 reports
• OSSEOTITE® CERTAIN® INT511

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  26 reports
• OSSEOTITE® CERTAIN® XIFNT610

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  26 reports
• OSSEOTITE® CERTAIN® IFNT411

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  25 reports
• OSSEOTITE® CERTAIN® INT413

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  23 reports
• OSSEOTITE® CERTAIN® IOSS485

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  22 reports
• OSSEOTITE® CERTAIN® INT3213

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  21 reports
• OSSEOTITE® CERTAIN® XIFNT415

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  20 reports
• OSSEOTITE® CERTAIN® XIFNT513

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  20 reports
• OSSEOTITE® CERTAIN® IFNT485

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  19 reports
• OSSEOTITE® CERTAIN® INT585

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  19 reports
• OSSEOTITE® CERTAIN® IFNT511

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  18 reports
• OSSEOTITE® CERTAIN® INT3285

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  14 reports
• OSSEOTITE® CERTAIN® IFNT413

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  13 reports
• OSSEOTITE® CERTAIN® INT415

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  13 reports
• OSSEOTITE® CERTAIN® INT513

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  13 reports
• OSSEOTITE® CERTAIN® IOSM313

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  13 reports
• OSSEOTITE® CERTAIN® IFNT3213

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  12 reports
• OSSEOTITE® CERTAIN® IOSM311

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  12 reports
• OSSEOTITE® CERTAIN® IOSS410

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  12 reports
• OSSEOTITE® CERTAIN® IFNT3211

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  11 reports
• OSSEOTITE® CERTAIN® INT610

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  11 reports
• OSSEOTITE® CERTAIN® XIFNT611

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  11 reports
• OSSEOTITE® CERTAIN® XIFNT613

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  11 reports
• OSSEOTITE® CERTAIN® IFNT3210

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  10 reports
• OSSEOTITE® CERTAIN® IFNT685

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  9 reports
• OSSEOTITE® CERTAIN® INT3215

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  9 reports
• OSSEOTITE® CERTAIN® IOSS413

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  9 reports
• OSSEOTITE® CERTAIN® IOSS511

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  8 reports
• OSSEOTITE® CERTAIN® IOSS585

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  7 reports
• OSSEOTITE® CERTAIN® IOSM310

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  6 reports
• OSSEOTITE® CERTAIN® IFNT610

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  5 reports
• OSSEOTITE® CERTAIN® XIFNT685

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  5 reports
• OSSEOTITE® CERTAIN® INT685

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  4 reports
• OSSEOTITE® CERTAIN® IOSS510

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  4 reports
• OSSEOTITE® CERTAIN® XIFNT515

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  4 reports
• OSSEOTITE® CERTAIN® IFNT611

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  3 reports
• OSSEOTITE® CERTAIN® IFNT613

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  3 reports
• OSSEOTITE® CERTAIN® INT515

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  3 reports
• OSSEOTITE® CERTAIN® IOSS415

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  3 reports
• OSSEOTITE® CERTAIN® IFNT415

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  2 reports
• OSSEOTITE® CERTAIN® IFNT513

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  2 reports
• OSSEOTITE® CERTAIN® IFOS411

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  2 reports
• OSSEOTITE® CERTAIN® INT611

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  2 reports
• OSSEOTITE® CERTAIN® IFNT3215

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• OSSEOTITE® CERTAIN® IFNT3285

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• OSSEOTITE® CERTAIN® INT613

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• OSSEOTITE® CERTAIN® INT615

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• OSSEOTITE® CERTAIN® IOSM315

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• OSSEOTITE® CERTAIN® IOSM318

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• OSSEOTITE® CERTAIN® IOSM385

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• OSSEOTITE® CERTAIN® IOSS418

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• OSSEOTITE® CERTAIN® IOSS513

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report

Recent OSSEOTITE CERTAIN adverse event reports

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

• InjurySep 30, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  It was reported loss of integration due to Peri-implantitis at tooth site 21.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50944161 ↗
• InjurySep 30, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  It was reported loss of integration due to peri implantitis at tooth site 24.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50943971 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  The doctor reports that the dental implants failed due to peri-implantitis at tooth sites 16 and 17.The doctor reports in the PER that the procedure was not concluded by placing another implants.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50931699 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  The doctor reports that the dental implants failed due to peri-implantitis at tooth sites 16 and 17.The doctor reports in the PER that the procedure was not concluded by placing another implants. Site grafted.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50931627 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to a peri-implantitis. Tooth site 16.Patient suffered from abscess and pain.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 50913581 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to an infection at tooth site 19. Implant become sore to chew on and patient was having "squishy" noise.Patient suffered from pain.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50798772 ↗
• InjuryAug 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to loss of integration and a peri-implantitis. Tooth site 37. Treatment included antibiotics, removal, curettage, and collagen bone grafting. Patient suffered from abscess, inflammation and pain.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50387066 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported that the abutment came off approximately one week after placement. The implant subsequently failed to integrate, with an infection and abscess present at tooth #7.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 50297402 ↗
• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  Doctor reported that implant was removed due to Peri-implantitis with complete loss of integration.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50268120 ↗
• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  Doctor reported that implant was removed due to Peri-implantitis with complete loss of integration. Tooth site 26.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50266169 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant was removed due to peri implantitis, tooth site 19.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50152631 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported patient developed subperiosteal abscess leading to graft resorption. Implant at tooth site 8 was removed due to infection.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 50113936 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported at time of exposure, peri implantitis was found. implant removed. Will replace at a later date. Tooth site 28.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50080650 ↗
• InjuryJul 29, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  It was reported implant was removed due to periimplantitis and loss of integration, discovered during clinical procedure. Tooth site 13.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50066519 ↗
• 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 50066514 ↗

Other ZimVie US Corp LLC products

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• 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
• Tapered SwissPlus12 models · 376 reports