Arthrex® AR-2655CLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867027480), received between Mar 2, 2017 and Sep 16, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2024Break; Break

  UPDATE (B)(6) 09-APR-2025: FURTHER INFORMATION WAS REQUESTED FROM THE CUSTOMER, TO CONFIRM A PLATE BREAKAGE DURING THE SURGERY AND A NEW CONTACT FROM THE OR MANAGEMENT PROVIDED DIFFERENT INFORMATION THAN THE PREVIOUS CONTACT. ACCORDING TO THE OR MANAGEMENT THE CLAVICLE PLATE DID NOT BREAK DURING THE SURGERY, BUT THE BREAKAGE OF THE PLATE OCCURRED AFTER THE SURGERY AND AFTER THE PATIENT WAS DISCHARGED. A REVISION SURGERY WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224862 ↗
• InjuryMar 30, 2021Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD A CLAVICLE FRACTURE THAT WAS FIXED ON (B)(6) 2020 WITH AN AR-2655CL CLAVICLE PLATE AND A QUANTITY SIX 3.5MM CORTEX SCREWS. MOST OF THE SCREWS BACKED OUT; RESULTING IN A NON-UNION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 11591226 ↗
• InjuryMar 30, 2021Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY TREATED WITH AN ARTHREX CLAVICLE PLATE AND 3.5MM CORTEX SCREWS. SEVERAL MONTHS AFTER THE PRIMARY SURGERY, THE SCREWS EVENTUALLY BACKED OUT; RESULTING IN A NON-UNION. THE PATIENT WAS REVISED ON (B)(6) 2021 USING AN AUTOGRAFT FROM THE ILLIAC CREST, AN ANTERIOR 2.7MM LOCKING PLATE AND A 3.5MM LCP SUPERIOR CLAVICLE PLATE.

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

  MAUDE report 11591150 ↗
• InjuryDec 16, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A LEFT CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2019. DUE TO PATIENT ISSUES WITH PAINFUL HARDWARE. THE PATIENT UNDERWENT A REVISION PROCEDURE (B)(6) 2019 AT A DIFFERENT FACILITY THAN THE ORIGINAL SURGERY CENTER. ALL ORIGINAL ARTHREX IMPLANTS WERE EXPLANTED DURING THE REVISION. NO PRODUCTS WERE IMPLANTED DURING THE REVISION PROCEDURE. THE EXPLANTED DEVICES ARE NOT AVAILABLE TO RETURN FOR EVALUATION. THE PRODUCTS WERE KEPT BY THE PATIENT. THE FOLLOWING ARE THE ARTHREX DEVICES THAT WERE EXPLANTED: AR-2655CL, CLAVICLE FRACTURE PLATE, CENTRAL THIRD -LEFT, (LOT 5261832), AR-2665-14H, FRAGMENT SCREW, (LOT 135138), AR-8835-16, LOW PROFILE SCREW (QTY 3), (LOT 10240456), AR-8835-16, LOW PROFILE SCREW (QTY 3), (LOT 10248912).

  Patient problems: Pain

  MAUDE report 9473043 ↗
• InjuryMar 2, 2017Break

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT HAD UNDERGONE AN INITIAL TAKEDOWN OF MALUNION AND ORIF PROCEDURE FOR A MID-SHAFT CLAVICLE FRACTURE WITH NON-ARTHREX PRODUCTS. PATIENT HAD RE-FRACTURED AT THE END OF THE INITIAL PLATING AND A SECOND ORIF SURGERY ((B)(6) 2016) WAS PERFORMED WITH THE SAME SURGEON AT THE SAME FACILITY, WHERE THE SURGEON EXPLANTED THE CLAVICLE PLATE AND SCREWS (NON-ARTHREX PRODUCTS) AND IMPLANTED A NEW CLAVICLE PLATE, AR-2655CL (LOT UNKNOWN). NO SPECIFIC INCIDENTS WERE REPORTED TO HAVE OCCURRED SINCE THE SECOND SURGERY AND IT WAS REPORTED THAT PATIENT WAS COMPLIANT. APPROXIMATELY 10 WEEKS POST OP FROM THE SECOND REPAIR, PATIENT REPORTED SUDDEN ONSET OF PAIN WHILE STANDING. X-RAYS WERE TAKEN WHICH CONFIRMED THE AR-2655CL CLAVICLE PLATE HAD BROKEN IN HALF. A REPAIR SURGERY DATE WAS NOT SET TO REMOVE THE BROKEN PLATE AND REVISE THE REPAIR; HOWEVER, A CONSULTATION HAS BEEN SCHEDULED FOR (B)(6) 2016 WITH THE PATIENT AND SURGEON TO SEE IF THE CLAVICLE HAS BEEN UNITED. PATIENT IS A MALE, (B)(6). **ON (B)(6) 2017: UPDATE: REP NOTIFIED THE DISTRIBUTOR THAT THE PATIENT HAD THE BROKEN CLAVICLE PLATE REMOVED IN A REVISION SURGERY ON (B)(6) 2017. THE SURGEON USED A NO

  Patient problems: Failure of Implant; Pain

  MAUDE report 6371754 ↗