Hex-Lock® SA451Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024016767), received between May 16, 2024 and May 16, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2024Fracture; Fracture
IT WAS REPORTED THAT THE SCREW AT TOOTH SITE #26 FRACTURED. IT WAS REPORTED THAT THE PATIENT CAME IN WITH CROWN IN HAND; SAYS IT BROKE OFF. THE SCREW BROKE OFF AT THE HEAD. UNABLE TO REMOVE THE THREAD PART OF THE SCREW. A WEEK FOLLOWING HAD TO REMOVE THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19329650 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.