Arthrex® AR-1588AL-CP2Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867395350), received between May 30, 2023 and Jul 27, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Patient Device Interaction Problem

  It was reported by a patient, through review of medical records, that on (b)(6)2025, the patient underwent ACL reconstruction. The operative report indicates the following Arthrex products were used for the procedure: AR-4580R FiberStitch (Lot Unknown), AR-4580S FiberStitch (Lot 25C05) AR-1588AL-CP2 Allograft GraftLink Implant System (Lot 15317362); AR-4580 FiberStitch (Lot 25D03), AR-4020-C-09 FastThread BioComposite Interference Screw, 9 x 20 mm (Lot 15454391) and AR-4020C-09 and AR-4020P-10 FastThread PEEK Interference Screw 10 mm × 20 mm (Lot 15231522A). Patient medical records support implantation of the AR-4020C-09 and AR-4020P-10 interference screws. Information provided by the patient alleges an AR-4030C-10 BioComposite Interference Screw, 10 x 30 mm may have been used and fractured during implantation; however, no such event is documented in the November 24, 2025 operative report. The exact intraoperative sequence, device utilization, and circumstances surrounding the alleged fracture of a device could not be conclusively determined from the available records. Following a reported traumatic event at home where the patient's left knee was hyperextended and twisted, the pati

  Patient problems: Failure of Implant

  MAUDE report 50006510 ↗
• InjuryJul 27, 2026Patient Device Interaction Problem

  It was reported by a patient, through review of medical records, that on (b)(6) 2025, the patient underwent ACL reconstruction. The operative report indicates the following Arthrex products were used for the procedure: AR-4580R FiberStitch (Lot Unknown), AR-4580S FiberStitch (Lot 25C05) AR-1588AL-CP2 Allograft GraftLink Implant System (Lot 15317362); AR-4580 FiberStitch (Lot 25D03), AR-4020-C-09 FastThread BioComposite Interference Screw, 9 x 20 mm (Lot 15454391) and AR-4020C-09 and AR-4020P-10 FastThread PEEK Interference Screw 10 mm × 20 mm (Lot 15231522A). Patient medical records support implantation of the AR-4020C-09 and AR-4020P-10 interference screws. Information provided by the patient alleges an AR-4030C-10 BioComposite Interference Screw, 10 x 30 mm may have been used and fractured during implantation; however, no such event is documented in the November 24, 2025 operative report. The exact intraoperative sequence, device utilization, and circumstances surrounding the alleged fracture of a device could not be conclusively determined from the available records. Following a reported traumatic event at home where the patient's left knee was hyperextended and twisted, the pat

  Patient problems: Failure of Implant

  MAUDE report 50006444 ↗
• MalfunctionMar 23, 2026Break

  ON 03-MARCH-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588AL-CP2 ALLOGRAFT GRAFTLINK AND SUTURE BRIDGE BROKE ON TOP OF THE FEMORAL TIGHTROPE WHILE TENSIONING FOR FINAL FIXATION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT WITH A 45-MINUTE DELAY TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662877 ↗
• MalfunctionDec 11, 2025Difficult to Open or Close; Difficult to Open or Close

  ON 11/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1588AL-CP2 FLIP CUTTER WAS UNABLE TO CLOSE AFTER REAMING THE FIRST TUNNEL, APPEARS THAT DEBRIS IS STUCK IN THE DEVICE. ISSUE DISCOVERED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777841 ↗
• MalfunctionOct 21, 2025Difficult to Open or Close; Difficult to Open or Close

  ON 10/15/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT A FLIPCUTTER II COMPONENT FROM THE AR-1588AL-CP2 ALLOGRAFT GRAFTLINK IMPLANT SYSTEM DID NOT OPEN AND COULD NOT BE USED. AS A RESULT, AN ADDITIONAL FLIPCUTTER II WAS OPENED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/20/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352348 ↗
• MalfunctionJul 3, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON 06/09/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1588AL-CP2 ALLOGRAFT GRAFTLINK THE FLIPCUTTER MADE A METAL SNAPPING SOUND AND THE OUTSIDE OF THE DRILL BIT DETACHED FROM THE INSIDE. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

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

  MAUDE report 22395904 ↗
• MalfunctionJun 13, 2025Positioning Failure; Positioning Failure

  ON 5/20/25, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT DURING AN ALLOGRAFT ACL RECONSTRUCTION CASE, THE TIGHTROPE MECHANISM FAILED FROM AN AR-1588AL-CP2 ALLOGRAFT GRAFTLINK IMPLANT SYSTEM. AFTER DRILLING THE TUNNELS AND ACHIEVING PRELIMINARY GRAFT TENSION, THE SURGEON PROCEEDED WITH FINAL TENSIONING ON THE FEMUR. DURING THIS STEP, A POP WAS FELT, AND THE TENSIONING SUTURES SLID FREELY AROUND THE RT BUTTON. UPON INSPECTION, THE GRAFT LOST TENSION, AND PULLING ON THE TIGHTROPE CONFIRMED A MECHANISM FAILURE, AS THE SUTURE SLID OUT COMPLETELY. TO COMPLETE THE CASE, THE ALLOGRAFT WAS REMOVED AND RE-PREPPED ON THE BACK TABLE USING NEW IMPLANT. WHILE NO HARM WAS CAUSED TO THE PATIENT, THIS ISSUE RESULTED IN AN ADDITIONAL 40 MINUTES OF CASE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205747 ↗
• InjuryApr 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT CALLED IN AN INQUIRY ABOUT THE MATERIAL COMPOSITION FOR THE AR-1588AL-CP2 IMPLANT SYSTEM, AR-1588TNT2 FIBERTAG TIGHTROPE II ABS, AR-1588RTT2-IB FIBERTAG® TIGHTROPE® II IMPLANT, AR-5511-CP IMPLANT SYSTEM, AND AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHOR. THERE WAS NO ALLEGATION OF PRODUCT DEFICIENCY OR ADVERSE EVENTS REPORTED WITHIN THIS INQUIRY. ON (B)(6) 2025, IT WAS REPORTED BY THE PATIENT VIA PHONE THAT SHE UNDERWENT AN ACL RECONSTRUCTION ON (B)(6) 2024 WHERE THE AR-1588AL-CP2 IMPLANT SYSTEM, AR-1588TNT2 FIBERTAG TIGHTROPE II ABS, AR-1588RTT2-IB FIBERTAG® TIGHTROPE® II IMPLANT, AR-5511-CP IMPLANT SYSTEM, AND AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHOR WERE IMPLANTED. THE PATIENT BEGAN TO EXPERIENCE AN ALLERGIC REACTION IN (B)(6) 2024 THE ALLERGIC REACTION WAS CONFIRMED BY A PHYSICIAN. THE PATIENT HAD A VISIBLE RASH, BLISTERS, AND OOZING OUT THE INCISIONS. HER LEG, KNEE, AND ANKLE WERE SWOLLEN WITH FLUID. IT WOULD GO AND COME, THIS HAPPENED UNTIL THE PROCEDURE IN (B)(6) 2024 WHERE THEY WENT IN AND CLEANED SCAR TISSUE. AFTER THIS PROCEDURE, THE REACTION WORSENED IT SPREAD TO THE WHOLE RIGHT LEG. THIS HAS BEEN AN ON AND OFF ISSUE SINCE

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21911184 ↗
• MalfunctionMay 30, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588AL-CP2 ALLOGRAFT IMPLANT SYSTEM FLIP CUTTER DRILL BROKE OFF. THIS WAS DISCOVERED DURING A CASE, DEVICE BREAKS DURING USE, SURGERY TIME WAS INCREASED BY ROUGHLY 30 MINUTES IN ORDER TO RETRIEVE BROKEN FLIP CUTTER PIECE.

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

  MAUDE report 17023737 ↗