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Stablecut® 20090119AGCRecalls & reported problems

Zimmer Orthopaedic Surgical Products, Inc. · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024496064), received between Jun 22, 2023 and Jun 22, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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

  • Tear, Rip or Hole in Device Packaging1

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.

  • MalfunctionJun 22, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    IT WAS REPORTED THAT OUTSIDE OF SURGERY THE STERILE PACKAGE WAS BROKEN AT THE DISTRIBUTOR. THERE WAS NO PATIENT INVOLVEMENT AND NO IMPACT TO PATIENT AND/ OR USER. DUE DILIGENCE INFORMATION COMPLETE. NO ADDITIONAL EVENT INFORMATION AVAILABLE. DURING EVALUATION, IT WAS DISCOVERED THAT THE OUTER PACKAGING HAD A SMALL PERFORATION THAT WENT ALL THE WAY THROUGH TO THE INNER PACKAGING AND COMPROMISED THE STERILIZATION OF THE PRODUCT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17180896 ↗

Other BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices

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