Arthrex® AR-4068-45LHRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867031487), received between Oct 24, 2022 and Oct 24, 2022 — classified as 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2022Break

  ON 10/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-4068-45LH SUTURELASSO¿ FOR HIP ARTHROSCOPY 45° CURVE LEFT AND AN AR-4068-45RH SUTURELASSO¿ FOR HIP ARTHROSCOPY 45° CURVE RIGHT HAD AN ISSUE. DURING A HIP ARTHROSCOPY / LABRAL REPAIR ON (B)(6) 2022, BOTH WIRED LASSOS INTO THE ABOVE TWO PRODUCTS BROKE EASILY UNDER A VERY SMALL AMOUNT OF PULL/TRACTION. THIS OCCURRED UPON WIRES PASSAGE TO SHUTTLE SUTURES. A PIECE BROKE FROM THE DEVICES AND THE BROKEN PIECES WERE FULLY RETRIEVED. NOTHING ADDITIONAL HAD TO BE DONE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657292 ↗