Arthrex® AR-2651CLRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867027404), received between Feb 19, 2019 and May 10, 2023 — classified as 3 injuries, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2023Break; Break

  IT WAS REPORTED THAT THE FOLLOWING DEVICES WERE IMPLANTED ON THE (B)(6) 2022: AR-2651CL (LOT: 5262203); AR-8835-16 (ILOT: 14999011); AR-8835L-16 (LOT: 14975878) AND AR-8835L-18 (LOT: 14946776). THE PLATE BROKE POST-OP WITHOUT EXTERNAL INFLUENCE. ON THE (B)(6) 2023, IT WAS REMOVED AND REPLACED WITH A NEW CLAVICLE FRACTURE PLATE (AR-2652CL). NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 16904801 ↗
• MalfunctionSep 19, 2022Break

  IT WAS REPORTED THAT AFTER AN INITIAL IMPLANTATION OF THE PLATE ON (B)(6) 2022 THE PLATE BROKE POST-OP WITHOUT EXTERNAL FORCES. THE PATIENT WENT TO THE HOSPITAL AND RECEIVED THE DIAGNOSIS THAT THE PLATE BROKE ON (B)(6) 2022 AND THE REVISION SURGERY WAS THEN PERFORMED ON (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 15445820 ↗
• InjuryJul 20, 2021Loose or Intermittent Connection

  IT WAS REPORTED THAT 6-8 WEEKS AFTER THE INITIAL IMPLANTATION THE DEVICE LOOSENED. A REVISION SURGERY HAD TO BE PERFORMED ON THE (B)(6) 2021. DURING THE REVISION SURGERY THE DEVICE WAS REMOVED AND THE REVISION SURGERY WAS FINISHED SUCCESSFULLY WITH A LONGER CLAVICULA PLATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12196605 ↗
• InjuryFeb 19, 2019Break; Material Twisted/Bent

  IT WAS REPORTED THAT AT THE 2-WEEK FOLLOW UP, AN X-RAY WAS TAKEN AND IT WAS SEEN THAT THE PLATE WAS BENT. NOW IT APPEARS TO BE BROKEN IN HALF. FOLLOW UP (B)(6) 2019; REVISION WAS DONE (B)(6) 2019, WITH THE SAME DOCTOR AND THE SAME FACILITY. THE PLATE AND SCREWS WERE REMOVED AND WILL BE RETURNED. ANOTHER MANUFACTURER'S DEVICE WAS USED IN THE REVISION. THE PATIENT CLAIMS TO HAVE BEEN POST-OP COMPLAINT AND HAD NO FALLS/INJURIES THAT CAUSED THE PLATE BREAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350746 ↗