Arthrex® AR-7282-25-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867363694), received between Jan 3, 2024 and May 5, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE WHILE TIGHTENING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961406 ↗
• MalfunctionMay 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE WHILE TIGHTENING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961388 ↗
• InjuryJun 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01 MAY 2024 IT WAS REPORTED BY A PRODUCT SURVEILLANCE SPECIALIST IN ARTHREX INC THAT THEY HAD RECEIVED A REPORT OF A POTENTIAL ADVERSE EVENT THAT OCCURRED DURING A CLINICAL STUDY IN THE UNIVERSITY OF WESTERN AUSTRALIA. THE ARTHREX PRODUCTS THAT WERE INVOLVED WERE: AR-1588R-IB ACL REPAIR TIGHTROPE, WITH INTERNAL BRACE, AR-2324PSLC-1 PEEK SWIVE LOCK C,4.75X19.1MM & AR-7282-25-1 FIBERRING WITH SHUTTLE SUTURE 25MM,SINGLE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED POST-OPERATIVE PARTIAL OCCLUSION OF PERONEAL VEIN, TREATED WITH ELIQUIS WITH FULL RECOVERY AND WITHOUT FURTHER SEQUALAE. MORE INFORMATION TO BE CONFIRMED. THERE WAS CASE INVOLVEMENT.

  Patient problems: Failure of Implant

  MAUDE report 19562801 ↗
• InjuryJun 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01 MAY 2024 IT WAS REPORTED BY A PRODUCT SURVEILLANCE SPECIALIST IN ARTHREX INC THAT THEY HAD RECEIVED A REPORT OF A POTENTIAL ADVERSE EVENT THAT OCCURRED DURING A CLINICAL STUDY IN THE UNIVERSITY OF WESTERN AUSTRALIA. THE ARTHREX PRODUCTS THAT WERE INVOLVED WERE: AR-1588R-IB ACL REPAIR TIGHTROPE, WITH INTERNALBRACE, AR-2324PSLC-1 PEEK SWIVELOCK C,4.75X19.1MM & AR-7282-25-1 FIBERRING WITH SHUTTLE SUTURE25MM,SINGLE. IT WAS REPORTED THAT THE PATIENT THAT UNDERWENT AN ACL REPAIR HAS HAD A LATERAL EXTRA-ARTICULAR TENODESIS ON THE SAME LEG AT 8 MONTHS POST- ACL REPAIR SURGERY. THERE WAS CASE INVOLVEMENT.

  Patient problems: Failure of Implant

  MAUDE report 19480439 ↗
• MalfunctionJan 3, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY THE SUTURE OF THE IMPLANT AR-1588R-IB (LOT: 15088451) DID NOT PULL THROUGH THE LOOP ON THE BUTTON. THE RINGS AR-7282-25-1 (LOT: 100001) FAILED (WERE NOT USABLE) DUE TO THE FAILURE OF THE BUTTON. ALL DEVICES WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE (B)(6) 08-DEC-2023 IT WAS CONFIRMED THAT THE DEVICE WAS ACTUALLY INTACT, BUT HAD TO BE DISCARDED IN THE END BECAUSE THE IMPLANT AR-1588R-IB (LOT: 15088451) FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438215 ↗
• MalfunctionJan 3, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY THE SUTURE OF THE IMPLANT AR-1588R-IB (LOT: 15088451) DID NOT PULL THROUGH THE LOOP ON THE BUTTON. THE RINGS AR-7282-25-1 (LOT: 100001) FAILED (WERE NOT USABLE) DUE TO THE FAILURE OF THE BUTTON. ALL DEVICES WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE (B)(6) 08-DEC-2023 IT WAS CONFIRMED THAT THE DEVICE WAS ACTUALLY INTACT, BUT HAD TO BE DISCARDED IN THE END BECAUSE THE IMPLANT AR-1588R-IB (LOT: 15088451) FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438214 ↗