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CERTAIN® IRE200URecalls & reported problems

ZimVie US Corp LLC · CERTAIN® UNIVERSAL RATCHET EXTENSION IMPLANT DRIVER (LONG) · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868029960), received between Mar 25, 2022 and Feb 17, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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.

Most reported problems

Device problems

  • Mechanical Problem1
  • Separation Failure1
  • Separation Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 17, 2023Separation Failure; Separation Problem; Separation Failure; Separation Problem

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16399537 ↗
  • MalfunctionMar 25, 2022Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT WHEN TORQUEING, THE RATCHET GOT STUCK IN THE IMPLANT DAMAGING THE INTERNAL HEX AND THREADS. ANOTHER IMPLANT AND DRIVER WAS USED TO COMPLETE THE PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13903127 ↗

Other ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS devices

All ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.