CERTAIN® LOCATOR® IMLOA003Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOCATOR® ABUTMENT 3.4MM(D) X 3MM(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 00844868006336), received between Oct 16, 2020 and Dec 1, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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.
Most reported problems
Device problems
- Fracture4
- Unintended Movement1
Patient problems
- No Information3
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionJan 6, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Code Available
MAUDE report 11127096 ↗MalfunctionNov 23, 2020Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENTS FRACTURE UPON PLACING THEM, TOQUE USED: 20MCM.
Patient problems: No Information
MAUDE report 10883288 ↗MalfunctionNov 23, 2020Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT FRACTURE UPON PLACING THEM, TOQUE USED: 20MCM.
Patient problems: No Information
MAUDE report 10883258 ↗MalfunctionOct 16, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10689116 ↗
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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 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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