Arthrex® AR-2654CRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867027473), received between Jan 15, 2019 and Sep 9, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2024Break; Break

  UPDATE AVOE 20-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON THE (B)(6) 2024 AND THE DEVICE IMPLANTED WAS THE PLATE AR-2654CR (LOT 15151774).

  Patient problems: Failure of Implant

  MAUDE report 20169984 ↗
• InjuryJan 27, 2020Break; Fracture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PLATE FRACTURE CLAVICLE OCCURRED FIVE WEEKS AFTER THE PRIMARY IMPLANTATION IN A YOUNG, HEALTHY PATIENT WITH AN ACUTE FRACTURE. IT WAS FURTHER REPORTED THAT THE PLATE WAS NOT PRE-BENT. THE BROKEN PLATE SHOWS THAT A PLASTIC DEFORMITY OCCURRED BEFORE THE FRACTURE. ADDITIONAL INFORMATION 10-JAN-2020. IT WAS FURTHER REPORTED THAT THE OSTEOSYNTHESIS CLAVICLE SURGERY WAS INITIALLY SUCCESSFULLY PERFORMED IN (B)(6) 2019. DUE TO THE INITIALLY REPORTED EVENT A REOSTEOSYNTHESIS WITH A SYNTHESIS PLATE WAS NEEDED AND THE REVISION SURGERY WAS PERFORMED SUCCESSFULLY ON (B)(6) 2019.

  Patient problems: Bone Fracture(s)

  MAUDE report 9631338 ↗
• InjuryJan 15, 2019Break

  IT WAS REPORTED THAT THE PATIENT NEEDED A REVISION TO REPLACE THE AR-2654CR CLAVICLE PLATE WITH AN AR-2653CR PLATE. THE PLATE BROKE; PER THE PATIENT, HE WOKE UP ONE DAY IN PAIN AND X-RAYS CONFIRMED THE PLATE HAD BROKEN. CASE WAS A CLAVICLE ORIF; ORIGINAL DATE OF SURGERY WAS (B)(6) 2018. BOTH THE ORIGINAL CASE AND THE REVISION WERE DONE AT THE SAME FACILITY WITH THE SAME SURGEON.

  Patient problems: Pain

  MAUDE report 8247838 ↗