Arthrex® AR-623-37Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867229921), received between Mar 22, 2024 and Jun 10, 2024 — classified as 2 malfunctions.

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

• MalfunctionJun 10, 2024Break; Break

  ON 05/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-623-37 FEMORAL IMPACTOR PLASTIC IS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499687 ↗
• MalfunctionMar 22, 2024Crack; Crack

  ON 3/7/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-623-6 KEEL PUNCH AND AN AR-623-37 IBAL TKA FEMORAL IMPACTOR HAD AN ISSUE. THE AR-623-6 KEEL PUNCH CONNECTION HAD BEEN WORN, MAKING IT DIFFICULT TO ATTACH TO OTHER INSTRUMENTS. ANOTHER INSTRUMENT WAS USED TO REMOVE THE INSTRUMENT. UPON COMPLETION OF THE CASE AND DURING THE INSPECTION OF INSTRUMENTS, IT WAS NOTICED THAT THE AR-623-37 IBAL TKA FEMORAL IMPACTOR HAD SUSTAINED A CRACK. NO SECOND SURGERY IS NEEDED, AND NO PATIENT HARM WAS NOTED. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 3/11/2024: NO PIECES BROKE IN THE PATIENT. THERE WAS NO CASE DELAY. IT IS UNKNOWN WHAT PRODUCT WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960553 ↗