CERTAIN LOCATORRecalls & reported problems across all models
ZimVie US Corp LLC · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 11 models of CERTAIN LOCATOR by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2019 and Oct 30, 2024 — classified as 1 injury, 32 malfunctions.
The most frequently reported specific device problem is “Fracture” (31 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 CERTAIN LOCATOR problems
Device problems
- Fracture31
- Adverse Event Without Identified Device or Use Problem1
- Unintended Movement1
Patient problems
- No Information15
- No Clinical Signs, Symptoms or Conditions10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Code Available2
- Failure of Implant1
- Insufficient Information1
- No Consequences Or Impact To Patient1
- Not Applicable1
CERTAIN LOCATOR models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CERTAIN® LOCATOR® IMLOA003IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- CERTAIN® LOCATOR® IMLOA004IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- CERTAIN® LOCATOR® IMLOA006IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- CERTAIN® LOCATOR® ILOA003IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- CERTAIN® LOCATOR® ILOA004IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- CERTAIN® LOCATOR® ILOA005IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- CERTAIN® LOCATOR® ILOA006IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- CERTAIN® LOCATOR® ILOA002IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- CERTAIN® LOCATOR® IMLOA005IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- CERTAIN® LOCATOR® ILOA001IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- CERTAIN® LOCATOR® IMLOA002IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent CERTAIN LOCATOR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20568318 ↗MalfunctionApr 5, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19048889 ↗MalfunctionSep 15, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT SCREW FRACTURED AT THE SITE AND HAD TO BE REMOVED THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 15426423 ↗MalfunctionSep 9, 2022Fracture; Fracture
THE DOCTOR REPORTS THAT THE PATIENT GOES TO HIS MEDICAL OFFICE WITH THE PROSTHESIS REMOVED AND THERE THE DOCTOR SHOWS THE LOCATOR BREAKAGE IN THE PART OF THE BODY. THE AFFECTED TOOTH POSITION IS #36. THE DENTAL PROCEDURE WAS NOT COMPLETED WITH ANOTHER ITEM. THE PATIENT DID NOT SUFFER ANY TYPE OF NEGATIVE IMPACT ON HIS HEALTH AS A CONSEQUENCE OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15392860 ↗MalfunctionMay 7, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO A FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14317655 ↗MalfunctionFeb 23, 2022Fracture; Fracture
THE DOCTOR REPORTS THAT DURING THE REVISION OF THE PROSTHESIS HE NOTICED THE FRACTURE OF THE ABUTMENT AND PROCEEDED TO CHANGE IT FOR A NEW ABUTMENT IMMEDIATELY IN THE SAME SURGERY WITHOUT ANY TYPE OF NEGATIVE IMPACT ON THE PATIENT'S HEALTH. THE AFFECTED TOOTH POSITION IS #33 THE ABUTMENT HAS FRACTURED ON THE PART OF THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13584634 ↗MalfunctionDec 1, 2021Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE LOCATOR ABUTMENT HAD BECOME LOOSE IN THE PATIENT'S MOUTH. ABUTMENT WAS REMOVED AND REPLACED WITH A NEW ONE.
Patient problems: Insufficient Information
MAUDE report 12908279 ↗InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER CORRECTED THE DEVICE LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12638413 ↗MalfunctionAug 12, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12311756 ↗MalfunctionJun 14, 2021Fracture; Fracture
IT IS REPORTED THAT THE LOCATOR ABUTMENT SCREW FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11990516 ↗MalfunctionMay 7, 2021Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11789458 ↗MalfunctionApr 30, 2021Fracture; Fracture
IT WAS REPORTED THAT THE LOCATOR SCREW AT TOOTH SITE 13 FRACTURED AND IT WAS REMOVED. IMPLANT IS IN GOOD STATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11754001 ↗MalfunctionApr 16, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11678586 ↗MalfunctionMar 1, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11392216 ↗MalfunctionFeb 22, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11357373 ↗
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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