CERTAIN® LOCATOR® IMLOA004Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOCATOR® ABUTMENT 3.4MM(D) X 4MM(H) · Class 2 · Implant
All models of CERTAIN LOCATOR (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868006343), received between Sep 28, 2020 and Apr 5, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture5
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Information2
- Failure of Implant1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionNov 2, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10770241 ↗MalfunctionSep 28, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10592223 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 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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