Arthrex® AR-1588AL-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867200654), received between Feb 26, 2020 and Jan 24, 2024 — classified as 1 injury, 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 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.

• MalfunctionJan 24, 2024Break; Break

  ON 1/6/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TIGHTROPE ABS FROM AN AR-1588AL-CP ALLOGRAFT GRAFTLINK KIT, SNAPPED DURING THE FINAL TENSIONING ON THE 14MM CONCAVE BUTTON FOR TIBIAL FIXATION. SURGEON HAD A TIBIAL WHIPSTITCH SUTURE ATTACHED TO THE TIGHTROPE, WHICH WAS USED TO PULL TENSION WHILE THE SOFT TISSUE SCREW WAS INSERTED. CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 1/9/2023: THIS WAS DISCOVERED DURING AN ACLR PROCEDURE, AND ALL THE BROKEN TIGHTROPE WAS REMOVED FROM INSIDE THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570472 ↗
• MalfunctionFeb 28, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588AL-CP ALLOGRAFT GRAFTLINK WAS BEING TIGHTENED DOWN TO THE TIBIA WITH A SPARE BTB TIGHTROPE, THE SUTURES BROKE JUST BELOW THE BUTTON CONSTRUCT. THE GRAFT WAS PULLED OUT AND A NEW ONE WAS OPENED. SURGEON HAD TO SLIGHTLY ALTER PROCEDURE WITH A FULL TIBIAL TUNNEL THROUGH THE CORTEX AND A 14MM BUTTON APPLIED USING AN ABS TIGHTROPE. THIS WAS DISCOVERED DURING AN ALL INSIDE ALLOGRAFT GRAFTLINK ACL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 13619981 ↗
• InjuryFeb 26, 2020Positioning Failure

  IT WAS REPORTED DURING AN ACL PROCEDURE THAT THE FEMORAL END OF THE FGLTS09575 FLEXIGRAFT GRAFTLINK GRAFT WAS RECEIVED SUTURED POORLY ACCORDING TO THE SURGEON AND REP. THE BULKY, FEMORAL SIDE WAS VISUALLY A CONCERN (SEE ATTACHED PICTURES) BEFORE IT PHYSICALLY BECAME SUCH A PROBLEM THAT THE GRAFT HAD TO BE REMOVED FROM THE PATIENT'S JOINT, TRIMMED DOWN, AND REATTACHED TO A NEW TIGHTROPE. THIS ADDED 1.5/2 HOURS TO THE CASE, AND QUITE A BIT OF FRUSTRATION. A 9.5 X 75 FGLTS WAS ORDERED, APPROXIMATELY 9 (TIB)/ 10(FEM) X 77 WAS RECEIVED. THE REP REPORTED THE TIB SIDE WAS GREAT. THE FEM SIDE HAD A SUTURE BULK STICKING OUT OF ONE SIDE. THE REP STATED IT WASN¿T THAT THE GRAFT WASN'T PERFECTLY 9.5 X 75, IT WAS THAT THE SUTURING OF THE FEMORAL SIDE WAS DONE POORLY. THERE WAS ALSO A BULK OF SUTURE THAT THE SURGEON COULD NOT SEAT INTO THE CROTCH THAT CAUSED A LOT OF FRUSTRATION. THE REPORTED ISSUES WERE NOTICEABLE IMMEDIATELY AFTER THAWING. ADDITIONAL INFORMATION RECEIVED ON 02/10/2020: THE REP REPORTED IN ADDITION TO PROLONGED ANESTHESIA THE PATIENT ALSO UNDERWENT ADDITIONAL TOURNIQUET TIME. THE GRAFT WAS SUCCESSFULLY IMPLANTED DURING THE SECOND IMPLANTATION ATTEMPT. THE REP REPORTED SOME PLAN

  Patient problems: Failure of Implant

  MAUDE report 9756015 ↗