Arthrex® AR-7500Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867229228), received between Apr 10, 2019 and Jun 2, 2025 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A HEALTHCARE PROFESSIONAL REPORTED THAT AN AR-3780SP KNEE FIBERTAK BUTTON, AN AR-8979P DX SWIVELOCK, AND AN AR-7500 SUTURETAPE WERE IMPLANTED IN A PATIENT DURING A SURGICAL PROCEDURE. APPROXIMATELY ONE YEAR LATER, THE PATIENT BEGAN EXPERIENCING PERSISTENT PAIN AND WAS REFERRED TO AN ALLERGIST FOR AN ALLERGEN PATCH TEST. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Pain

  MAUDE report 22125808 ↗
• MalfunctionApr 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE SUTURE TORE. 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 21890500 ↗
• MalfunctionAug 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A MENISCAL KNEE SURGERY THE SUTURE TORE NEAR THE NEEDLE. 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 19961910 ↗
• MalfunctionAug 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A MENISCAL KNEE SURGERY THE SUTURE TORE NEAR THE NEEDLE. 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 19917333 ↗
• MalfunctionAug 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A MENISCAL KNEE SURGERY THE SUTURE TORE NEAR THE NEEDLE. 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 19917255 ↗
• InjuryJan 17, 2023Patient Device Interaction Problem; Material Integrity Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-7500 SUTURETAPE AND AN BC PUSHLOCK ANCHOR, UNKNOWN PART NUMBER, WERE IMPLANTED IN THE PATIENT DURING A PROCEDURE LATE (B)(6) 2022. THE PATIENT DEVELOPED AN INFECTION POST-OPERATIVE AND UNDERWENT A ATFL REPAIR REVISION SURGERY ON (B)(6) 2022. IT WAS REPORTED THAT THE SUTURETAPE BECAME BRITTLE AND BOTH THE AR-7500 SUTURETAPE AND AN BC PUSHLOCK WERE EXPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 16182921 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-2923PS PEEK PUSHLOCK AND AN AR-7500 SUTURETAPE WAS IMPLANTED SUCCESSFULLY INTO PATIENT DURING AN ARTHROSCOPY RIGHT SHOULDER WITH CAPSULORRHAPHY. AFTER THE PROCEDURE THE PATIENT COMPLAINT OF PAIN AND TIGHTNESS AND SINCE THE PROCEDURE, PATIENT WAS NOT PROGRESSING WITH PHYSICAL THERAPY. PATIENT WAS REFERRED FOR A SECOND OPINION AND HAD ANOTHER ARTHROSCOPY PROCEDURE. DURING THE PROCEDURE, SURGEON DISCOVERED THE TISSUE SURROUNDING THE ANCHORS TO BE RED AND INFLAMED. THE ANCHORS WERE REMOVED ALONG WITH THE SURROUNDING IRRITATED TISSUES. PATIENT HAS A KNOWN ALLERGY TO NEOPRENE.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Inflammation; Pain

  MAUDE report 13569549 ↗
• MalfunctionJun 21, 2021Break

  IT WAS REPORTED THAT WHEN THE AR-7500 TAPE WAS LOADED INTO THE KNEE SCORPION AND INSERTED IT INTO THE MENISCUS, THE TAPE BROKE. NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032323 ↗
• InjuryDec 10, 2019Patient-Device Incompatibility

  IT WAS REPORTED THAT SUTURETAPE WAS USED DURING A PROCEDURE ON A PATIENT. THE PATIENT BEGAN TO EXPERIENCE A REJECTION OF THE SUTURETAPE AND THUS, HAD IT REMOVED. ADDITIONAL INFORMATION PROVIDED 11/21/2019: THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2019. IT WAS A REVISION OF ACROMIAL AND RCR PROCEDURE. THE PATIENT WAS EXPERIENCING WOUND DRAINING AND ITCHING IN HER FEET. THE SUTURETAPE WAS REMOVED ON (B)(6) 2019. ADDITIONAL INFORMATION PROVIDED 11/27/2019: THE PATIENT UNDERWENT THE REVISION DUE TO NON-UNION. THE DATE OF THE ORIGINAL PROCEDURE IS UNKNOWN. SINCE THE REMOVAL, THE PATIENT HAS TAKEN A VARIETY OF SUTURES TO HER ALLERGIST TO TEST. THE SURGEON BELIEVES HER GENETICS ARE THE ISSUE-NOT THE SUTURETAPE.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; No Code Available

  MAUDE report 9443710 ↗
• InjuryApr 10, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2019 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-1349M / LOT: 10253224 / QTY: 1 AR-1355 / LOT: 10216387 / QTY: 1 AR-7500 / LOT: 100038 / QTY: 2 AFTER THE SURGERY, INFECTION OF RESIDENT BACTERIA WAS OBSERVED AROUND THE POST SCREW ON THE TIBIAL SIDE. WHETHER THE STERILIZATION AND PROCEDURES OF INSTRUMENTS USED FOR SURGERY WERE APPROPRIATE IS CURRENTLY UNDER INVESTIGATION BY THE FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: ONE DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED 38°C FEVER. 3 DAYS AFTER, THE PATIENT EXPERIENCED MILD SWELLING OF LOWER RIGHT THIGH PROXIMAL PART. 5 DAYS AFTER, THE PATIENT EXPERIENCED 39 DEGREE FEVER. BLOOD WAS TAKEN AND INFLAMMATORY RESPONSE WAS HIGH.

  Patient problems: Fever; Inflammation; Swelling; Unspecified Infection

  MAUDE report 8500871 ↗
• InjuryApr 10, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2019 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-1349M / LOT: 10253224 / QTY: 1, AR-1355 / LOT: 10249019 / QTY: 1, AR-7500 / LOT: 100038 / QTY: 1. AFTER THE SURGERY, INFECTION OF RESIDENT BACTERIA WAS OBSERVED AROUND THE POST SCREW ON THE TIBIAL SIDE. WHETHER THE STERILIZATION AND PROCEDURES OF INSTRUMENTS USED FOR SURGERY WERE APPROPRIATE IS CURRENTLY UNDER INVESTIGATION BY THE FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: THREE DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED OVER 40°C FEVER AND REDNESS, MILD SWELLING OF LOWER RIGHT THIGH PROXIMAL PART, AND FEELING OF HEAT. 5 DAYS AFTER, BLOOD WAS TAKEN AND INFLAMMATORY RESPONSE WAS HIGH.

  Patient problems: Burning Sensation; Fever; Inflammation; Post Operative Wound Infection; Swelling

  MAUDE report 8500774 ↗
• InjuryApr 10, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2019 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-1349M / LOT: 10217761 / QTY: 1, AR-1355 / LOT: 10237190 / QTY: 1, AR-7500 / LOT: S20197 / QTY: 2. AFTER THE SURGERY, INFECTION OF RESIDENT BACTERIA WAS OBSERVED AROUND THE POST SCREW ON THE TIBIAL SIDE. WHETHER THE STERILIZATION AND PROCEDURES OF INSTRUMENTS USED FOR SURGERY WERE APPROPRIATE IS CURRENTLY UNDER INVESTIGATION BY THE FACILITY. *ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: FOUR DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED MILD SWELLING OF LOWER RIGHT THIGH PROXIMAL PART. 8 DAYS AFTER, THE PATIENT EXPERIENCED 38°C DEGREE FEVER AND REDNESS. 10 DAYS AFTER, BLOOD WAS TAKEN AND INFLAMMATORY RESPONSE WAS HIGH.

  Patient problems: Fever; Inflammation; Post Operative Wound Infection; Swelling

  MAUDE report 8500725 ↗