Arthrex® AR-14242Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867017405), received between Aug 1, 2018 and Dec 26, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2025Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION WAS RECEIVED ON (b)(6) 2026:ON (b)(6) 2025, THE FAILED PROXIMAL HUMERAL PLATE WAS INITIALLY IDENTIFIED DURING A CLINIC VISIT. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PREVIOUSLY IMPLANTED DEVICES WERE REMOVED. PER COMMUNICATION FROM THE OPERATIVE SURGEON WHO PERFORMED THE REVISION PROCEDURE, THE BUSHINGS WERE OBSERVED TO HAVE DISENGAGED FROM THE PLATE.ADDITIONAL INFORMATION WAS RECEIVED ON (b)(6) 2026:ALL IMPLANTED ARTHREX DEVICES FROM THE REVISION PROXIMAL HUMERUS ORIF PERFORMED ON (b)(6)2025 WERE EXPLANTED DURING A SUBSEQUENT REVISION PROXIMAL HUMERUS PROCEDURE WITH PLACEMENT OF A SPACER ON (b)(6) 2026. NO ARTHREX IMPLANTS WERE IMPLANTED DURING THE (b)(6) 2026 PROCEDURE. THE REVISION PROCEDURE WAS PERFORMED AT THE SAME FACILITY AS THE PRIOR REVISION PROXIMAL HUMERUS ORIF CONDUCTED ON(b)(6) 2025; HOWEVER, THE PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS STABLE. THE SALES REPRESENTATIVE WAS NOT PRESENT FOR THE (b)(6) 2026 SURGERY AND REPORTED BEING INFORMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS SCHEDULED TO UNDERGO A TOTAL SHOULDER REPLACEMENT IN MAY.ADDITIONAL INFORMATION WA

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23896827 ↗
• InjuryAug 1, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROXIMAL SUTURE PLATE REMOVAL PROCEDURE, AS THE SURGEON WENT TO REMOVE THE SCREWS, THE SCREW TIPS ON EACH SCREW BECAME DETACHED AND REMAINED IN THE FAR CORTEX OF THE PATIENT¿S HUMERUS. THE SURGEON DID NOT ATTEMPT TO RETRIEVE THE TIPS AND NO EXTRA SURGERY IS SCHEDULED TO REMOVE THE TIPS EITHER. THE PATIENT CONDITION WAS STABLE. HARDWARE REMOVED: AR-14003, AR-14128NL, AR-14124NL, AR-14242, AR-14240, AR-14236, AR-14234, AR-14126. ADDITIONAL INFORMATION PROVIDED 7/27/2018: THE REMOVAL SURGERY DATE WAS (B)(6) 2018. THE ORIGINAL SURGERY (FIRST IMPLANTED DATE) IS (B)(6) 2017. THE SCREWS AND PLATE WERE REMOVED AS THE ONE WAS HEALED. THE IMPLANTATION OF THE PLATE AND SCREWS WAS TEMPORARY. ALL EXPLANTED SCREWS WERE DISCARDED.

  Patient problems: No Information

  MAUDE report 7738700 ↗