GMRS 6495-3-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327048919), received between Jan 31, 2019 and Oct 20, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K023087, K222056, K233261); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2025Degraded; Unstable; Degraded; Unstable

  NO NEW INFORMATION

  Patient problems: Joint Laxity

  MAUDE report 23334677 ↗
• InjuryJun 23, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  REVISION OF COMPETITOR IMPLANTS, LEFT KNEE. IT WAS REPORTED THAT WHEN THE IMPLANT WAS REMOVED FROM THE INTACT/ UNDAMAGED OUTER BOX, THE OUTER STERILE BLISTER WAS CRACKED AROUND THE RIM, AND THE INNER STERILE BLISTER WAS CRACKED AND BROKEN ALL OVER. DUE TO STERILITY CONCERNS, THE IMPLANT WAS REFUSED. BECAUSE ANOTHER IMPLANT SIZED SMALL WAS NOT AVAILABLE TO THE O.R., SURGEON DECIDED TO CLOSE THE PATIENT. SURGEON PLANS TO ADDRESS THE PATIENT'S KNEE AGAIN IN APPROXIMATELY A WEEK. APPROXIMATELY 45 MINUTES TO 1 HOUR LAPSED FROM THE TIME THE OUTER BLISTER WAS OBSERVED TO CLOSING THE PATIENT. THE PACKAGING WAS DISPOSED BEFORE THE REP COULD TAKE PICTURES. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON AT THIS TIME. UPDATE PER THE SALES REP: ULTIMATELY THE COMPETITOR WAS ALREADY OUT AND THE PATIENT WAS CLOSED WITH AN INCOMPLETE CONSTRUCT. UPDATE (B)(6) 2023: REP REPORTING SECOND SURGERY ON (B)(6) 2023 PROVIDED ADDITIONAL DETAILS FOR THIS CASE: AFTER THE PACKAGING ISSUE WHICH OCCURRED AS ABOVE, SURGEON IMPLANTED A ROD AND SOME CEMENT AS A SPACER CONSTRUCT. REP ALSO CONFIRMED THAT THE IMPLANT REPORTED IN THIS PI WAS VERY LIKELY FROM LOANERS AS NEITHER THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189402 ↗
• MalfunctionJan 31, 2019Packaging Problem; Packaging Problem

  A REPRESENTATIVE FROM THE HOSPITAL REPORTED THE FOLLOWING EVENT : " THE EXTERNAL PACKAGING OF THE IMPLANT IS DEFECTIVE. WHEN OPENED, THE PLASTIC PART BROKE AND REMAINED STUCK TO TYVEK. THE PRIMARY PACKAGING OF THE IMPLANT IS INTACT. THE IMPLANT COULD THUS BE SQUARE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8293046 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023087, K222056, K233261. One submission often covers many models, so check the product and lot details in each record.

• Z-2732-2024 · Aug 5, 2024 · Open, Classified
  Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
• Z-2624-2010 · May 5, 2005 · Terminated
  GMRS Extension Piece, 60 mm; Sterile Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick, Ireland. The Global Modular Replacement System is intended to be used