Arthrex® AR-623-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867198388), received between Mar 27, 2023 and Aug 31, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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

Recent adverse event reports

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

• MalfunctionAug 31, 2023Break; Break

  ON 08/03/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-623-7 KEEL PUNCH AND AN AR-623-36 TIBIAL IMPACTOR BROKE. THIS OCCURRED DURING A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2023, THE TAPER ON THE KEEL PUNCH SNAPPED OFF WHEN TRYING TO REMOVE IT FROM THE BONE. THE TIBIAL IMPACTOR BROKE DURING THE IMPACTION OF THE IMPLANT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17662459 ↗
• MalfunctionMar 27, 2023Break; Break

  ON 03/09/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-623-7 IBALANCE® TKA METAL PIECE BROKE OFF INTO AN IMPACTION HANDLE. THIS OCCURRED DURING A TKA CASE ON (B)(6) 2023. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION IS REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16618569 ↗