Arthrex® AR-7237Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867041738), received between Feb 5, 2019 and Jun 13, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/18/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1400TB BIO-INTERFERENCE SCREW FULL THREAD, AN AR-1588T ACL TIGHTROPE, (3) AR-2324BCC-2 BIO COMPOSITE SWIVELOCK, (3) AR-4500 MENISCAL CINCH, (4) AR-7200 FIBERWIRE, AND (2) AR-7237 FIBERTAPE WERE ALL IMPLANTED IN THE PATIENT. THIS ACL AND LIGAMENT PROCEDURE TOOK PLACE ON (B)(6) 2023. PATIENT DEVELOPED AN INFECTION POST OPERATIVE AND PATIENT REMAINS ADMITTED TO THE HOSPITAL FOR TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 5/15/2024: THE PATIENT HAS NOT UNDERGONE REVISION SURGERY, AND NO FURTHER INFORMATION HAS BEEN RECEIVED REGARDING THIS INCIDENT.

  Patient problems: Unspecified Infection

  MAUDE report 19533015 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/18/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1400TB BIO-INTERFERENCE SCREW FULL THREAD, AN AR-1588T ACL TIGHTROPE, (3) AR-2324BCC-2 BIO COMPOSITE SWIVELOCK, (3) AR-4500 MENISCAL CINCH, (4) AR-7200 FIBERWIRE, AND (2) AR-7237 FIBERTAPE WERE ALL IMPLANTED IN THE PATIENT. THIS ACL AND LIGAMENT PROCEDURE TOOK PLACE ON (B)(6) 2023. PATIENT DEVELOPED AN INFECTION POST OPERATIVE AND PATIENT REMAINS ADMITTED TO THE HOSPITAL FOR TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 16303006 ↗
• InjuryAug 24, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED BY A PATIENT'S RELATIVE, VIA THE ARTHREX WEBSITE, THAT THE FEMALE PATIENT HAD A SPINE PROCEDURE YEARS AGO DURING WHICH THE SURGEON USED ARTHREX FIBERTAPE TO SOFT FUSE THE SPINE. PATIENT HAS BEEN EXPERIENCING GREAT DIFFICULTIES WITH SCAR TISSUE AND REPORTER STATES THE FIBERTAPE HAS FAILED. AT THE TIME OF INITIAL REPORT NO SPECIFIC ARTHREX FIBERTAPE PRODUCT NUMBER, SURGEON NAME OR FACILITY INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION OBTAINED 8/4/2020: PATIENT UNDERWENT A C2-C7 SPINAL FUSION PROCEDURE ON (B)(6) 2016. ARTHREX FIBERTAPE HAS BEEN REPORTED TO HAVE BEEN USED DURING THE SURGERY. SPECIFIC PART NUMBER IS UNKNOWN AT THIS TIME. THE FUSION PERFORMED BY THE SURGEON FAILED AND THE PATIENT UNDERWENT A REVISION PROCEDURE BY A DIFFERENT SURGEON. THE REVISION WAS PERFORMED (B)(6) 2018. THE PATIENT IS REPORTED TO STILL SUFFER FROM A LOT OF SCAR TISSUE IN HER SPINE THAT IS PRESSING ON HER CORD. ADDITIONAL INFORMATION OBTAINED 8/5/2020: USING THE FACILITY PURCHASES OF FIBERTAPE A MOST LIKELY PART NUMBER HAS BEEN SELECTED BASED ON THE DATE OF PURCHASE ((B)(6) 2016. THE MOST LIKELY PART NUMBER TO BE REPORTED WILL BE AR-7237 (LOT 10016315).

  Patient problems: Failure of Implant; Scar Tissue

  MAUDE report 10442265 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ARTHREX DEVICE AR-7237 WAS USED. THE TAPE WAS INSERTED ACROSS THE METACARPALS TO STABILIZE THE METACARPAL ARCH. AFTER 6 MONTHS OF INSERTION THE PATIENT HAD ALLERGIC REACTIONS. NO FURTHER INFORMATION RECEIVED AT THE MOMENT.

  Patient problems: Reaction

  MAUDE report 9985554 ↗
• InjuryJun 11, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  AFTER AN INITIAL ANTERIOR CRUCIATE LIGAMENT SURGERY (RECORDED WITH (B)(4)) PATIENT CAME FOR CONSULTATION AND SHOWED THE CLINICAL PICTURE OF A MOVEMENT RESTRICTION WITH PAINFUL EPISODES. MRI SHOWED A SIGNIFICANTLY ENLARGED MEDIOPATELLAR PLICA. BASED ON THE FINDINGS, AGREEMENT OF ARTHROSCOPIC SURGERY WITH RESECTION OF THE ADHESIONS. THE SECOND SURGERY TOOK PLACE ON (B)(6) 2018. DIAGNOSIS: RESTRICTED MOVEMENT OF RIGHT KNEE JOINT, PLICA MEDIOPATELLARIS / SUSPECTED CYCLOPS AFTER ANTERIOR CRUCIATE LIGAMENT PLASTIC. PROCEDURE PERFORMED: PARTIAL MENISCECTOMY. THE SURGERY WAS AN ARTHROSCOPY, WITH ANCHOR SCREW, RESECTION OF SCARRING, RESECTION OF CLEAR PLICA MEDIOPATELLARIS IN RIGHT KNEE JOINT. EVALUATION POST-OP: THE EXAMINATION AFTER END OF ANAESTHESIA SHOWS CORRECT MOBILITY TO THE EXTENT PERMITTED. PART NUMBER AR-7237 WAS INVOLVED IN SURGERY. NO FURTHER INFORMATION WILL BE PROVIDED. UPDATE 08-AUGUST-2019: AFTER REVIEW OF THE FACILITY SALES IT WAS DISCOVERED THAT THE ORIGINAL PART NUMBER (AR-7237) PROVIDED WAS INCORRECT. THE CORRECT PART NUMBER, VERIFIED BY FACILITY SALES ORDERS, IS AR-7237-7.

  Patient problems: Limited Mobility Of The Implanted Joint; Scarring

  MAUDE report 8686247 ↗
• InjuryJun 7, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT (ACL) REINSERTION (TWO 0 FIBERLINK, FEMORAL ACL TIGHT ROPE RT), ANTERIOR CRUCIATE LIGAMENT AUGMENTATION PLASTIC (DOUBLE FIBERTAPE, TIBIAL ANCHOR SCREW), MICROFRACTURING LATERAL CONDYLAR CHEEK, OUTER MENISCUS PARTIAL RESECTION RIGHT KNEE ON (B)(6) 2018. PATIENT INCURRED A DISTORTION TRAUMA OF BOTH KNEE JOINTS DURING A SKI FALL 4 DAYS AGO, ON THE RIGHT SIDE PROXIMAL ANTERIOR CRUCIATE LIGAMENT RUPTURE WITH LONG TIBIAL STUMP. THE FINAL ARTHROSCOPIC CONTROL SHOWS A PERFECT ANATOMICAL CORRECT RE-INSERTION OF THE ANTERIOR CRUCIATE LIGAMENT WITH ABSOLUTELY STABLE VENTRALLY LOCATED FIBERTAPE AUGMENTATION. FINAL DOCUMENTATION, INSERTION OF A 10 REDON-DRAINAGE INTRAARTICULARLY. SUBCUTANEOUS SUTURE, TIBIAL SKIN SUTURE. STERILE BANDAGE, ELASTIC WRAPPING. POSTOPERATIVE EVALUATION: THE EXAMINATION AFTER THE END OF ANAESTHESIA SHOWS CORRECT MOBILITY AND ABSOLUTELY STABLE LIGAMENT CONDITIONS TO THE EXTENT PERMITTED. ADDITIONAL INFORMATION OBTAINED VIA E-MAIL: AFTER SURGERY PATIENT HAD THE FEELING THAT THE KNEE FEELS DIFFERENT AND CANNOT BE BENT VERY WELL. KNEE FILLED WITH LIQUID. PATIENT WAS ARTHROSCOPIED AND BURSA WAS REMOVED. PA

  Patient problems: Adhesion(s); Hypersensitivity/Allergic reaction; Loss of Range of Motion; Pain

  MAUDE report 8679777 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE AN ACHILLES SPEEDBRIDGE PROCEDURE ON (B)(6) 2018 DURING WHICH A BIO-COMPOSITE ACHILLES SPEEDBRIDGE WITH JUMPSTART IMPLANT SYSTEM, AR-8928BCJ-CP (LOT 10158865), WAS IMPLANTED. 7-10 DAYS POST OP THE PATIENT TESTED POSITIVE FOR STAPH INFECTION. PATIENT WAS PRESCRIBED ON ROUND OF IV ANTIBIOTICS, BUT SYMPTOMS WERE STILL PRESENT. SURGEON DECIDED TO PERFORM A SECOND SURGERY WHICH TOOK PLACE ON (B)(6) 2019. THE SECOND PROCEDURE WAS PERFORMED AT A DIFFERENT FACILITY BY THE SAME SURGEON WHO PERFORMED THE ORIGINAL PROCEDURE. DURING THE SECOND SURGERY THE SURGEON EXPLANTED THE FIBERTAPE AND TIGERTAPE WHICH ARE COMPONENTS OF THE AR-8928BCJ-CP BIO-COMPOSITE ACHILLES SPEEDBRIDGE WITH JUMPSTART IMPLANT SYSTEM. THE BIO-COMPOSITE ANCHORS FROM THE IMPLANT SYSTEM WERE NOT EXPLANTED AND REMAIN IN THE PATIENT. NO DEVICES WERE IMPLANTED DURING THE SECOND SURGERY.

  Patient problems: Bacterial Infection

  MAUDE report 8305828 ↗