Arthrex® AR-2652CLRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867027428), received between Dec 7, 2016 and Apr 3, 2025 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ISSUES OCCURRED AFTER THE IMPLANTATION OF AN CLAVICLE FRACTURE PLATE WITH MULTIPLE SCREWS IN (B)(6) 2024. SINCE THE IMPLANTATION THE PATIENT SUFFERS FROM PERSISTENT SYMPTOMS AND POSSIBLY INFLAMMATORY REACTIONS, THE CAUSE OF WHICH IS STILL UNCLEAR. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21764152 ↗
• InjuryFeb 4, 2024Break; Break

  ON 01/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT UNDERWENT A CLAVICLE FRACTURE PROCEDURE ON 12/05/2023 WHERE AN AR-2652CL CLAVICLE FRACTURE PLATE, AN AR-8835-14 LOW PROFILE SCREW, (2) AR-8835-16 LOW PROFILE SCREWS, AN AR-8835CL-12 KREULOCK COMPRESSION SCREW, (2) AR-8835CL-14 KREULOCK COMPRESSION SCREWS, AN AR-8835-10 LOW PROFILE SCREW, AN AR-7268 FIBERTAPE® CERCLAGE WITH TIGERLINK, AND AN AR-7268T TIGERTAPE® CERCLAGE WITH FIBERLINK WERE IMPLANTED. FIVE WEEKS POST-OP, THE PATIENT REPORTED HEARING OR FEELING A POP. AN X-RAY WAS TAKEN THAT CONFIRMED THAT THE AR-2652CL PLATE HAD BROKEN. ON 01//17/2024, A REVISION SURGERY WAS PERFORMED WHERE THE IMPLANTED DEVICES WERE REMOVED. THE REVISION WAS COMPLETED USING A DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: Failure of Implant

  MAUDE report 18637558 ↗
• MalfunctionDec 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY A LEGAL REPRESENTATIVE THAT A PATIENT HAD A CLAVICLE SURGERY IN 2017 AT NEW YORK HOSPITAL. THE REPRESENTATIVE REPORTED THAT THE RECORDS INDICATED THAT A ¿9 HOLE PLATE¿ ¿ARTHREX PLATE¿ WAS USED FOR A RIGHT CLAVICLE SURGERY AND STATED THAT THE IMPLANT LOG WAS HAND WRITTEN AND STATED ¿AR -2652CL OR 26526L¿. THE MOST LIKELY PART NUMBER IS BELIEVED TO BE THE AR-2652 CL 8 HOLE PLATE. NO LOT NUMBER WAS PROVIDED. THE REPRESENTATIVE FURTHER REPORTED THAT POST OPERATIVELY THE PATIENT TREATED WITH A MASSAGE THERAPIST AND THE SERVICES PROVIDED CAUSED ISSUES WITH THE CLAVICLE PLATE THAT WAS IMPLANTED. IT WAS UNKNOWN WHAT THOSE ISSUES WERE OR IF A REVISION SURGERY TOOK PLACE. TO DATE, WE HAVE NOT RECEIVED ANY FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18276088 ↗
• InjuryOct 5, 2023Break; Break

  IT WAS REPORTED THAT A CLAVICLE FRACTURE PLATE BROKE POST OPERATIVE 6 WEEKS AFTER THE IMPLANTATION ON (B)(6) 2023. THE PATIENT FURTHER REPORTED THAT NO TRAUMA HAS OCCURRED. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2023. *** 15-SEP-2023 UPDATE DW. FURTHER INFORMATION WERE PROVIDED THAT THE EVENT IS RELATED TO AN AR-2652CL WITH THE LOT: 5262127.

  Patient problems: Failure of Implant

  MAUDE report 17877339 ↗
• InjuryAug 15, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE SCREW HAS LOOSENED IN THE CLAVICLE PLATE. NO FURTHER INFORMATION RECEIVED. 27-JUN-2023 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT THE FOLLOWING DEVICES BECAME LOOSE POST OP. AR-2652CL BATCH: 5262102, AR-8835L-14 BATCH: 15040867, AR-8835-14 BATCH: 10694746, 2X AR-8835-16 BATCH: 1072011, 3X AR-8835-18 BATCH: 10591283, AR-8827-14 BATCH: 1074240. AS THE REPORTED DEVICES ARE AVAILABLE FOR RETURN A REVISION SURGERY HAD TO BE PERFORMED BUT NO FURTHER INFORMATION WERE PROVIDED WHEN THE REVISION SURGERY WAS PERFORMED. 13-JUL-2023 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT A REVISION SURGERY WAS PERFORMED WITH A DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: Failure of Implant

  MAUDE report 17549799 ↗
• InjuryAug 4, 2023Break; Capacitative Coupling; Break; Capacitative Coupling

  IT WAS REPORTED THAT AN ARTHREX PLATE BROKE AFTER THE IMPLANTATION. NO FURTHER INFORMATION RECEIVED. (B)(6) 2023 UPDATE DW. FURTHER INFORMATION WERE PROVIDED THAT THE BROKEN PLATE WAS AN AR-2652CL WITH THE BATCH 5261949. IT WAS FURTHER REPORTED THAT THE FOLLOWING DEVICES WERE EXPLANTED AS WELL: 2X AR-8835L-14 BATCH 10732033, 2X AR-8835-14 BATCH 10732033, 1X AR-8827-18 BATCH 1071964, 1X THIRD-PARTY IMPLANT. (B)(6) 2023 UPDATE DW. FURTHER INFORMATION WERE PROVIDED THAT A REVISION SURGERY WAS PERFORMED WITH A DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: Failure of Implant

  MAUDE report 17465823 ↗
• InjuryMay 10, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE FOLLOWING DEVICES WERE IMPLANTED ON THE (B)(6) 2023: AR-2652CL (LOT: 5262102); AR-8835L-16 (LOT: 14975878); AR-8835L-18 (LOT: 14975879), AR-8835-16 (LOT: 14999011) AND AR-8835-18 (LOT: 14983034). THE PLATE BENT 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 16904854 ↗
• InjurySep 6, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2652CL CLAIVCLE PLATE BROKE THIS WAS DISCOVERED AFTER USE, THE ORIGINAL SURGERY WAS (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15362698 ↗
• InjuryMar 8, 2021Fracture

  IT WAS REPORTED THROUGH THE FDA'S MEDWATCH PROGRAM THAT AN AR-2652CL CLAVICLE PLATE FAILED POST-OPERATIVELY. THE PATIENT FELT A POP WHILE DRIVING AND LIFTING HIS ARM AND HIS SURGEON CONFIRMED THAT THE PLATE FRACTURED AT THE PREVIOUS FRACTURE SITE. NO FACILITY OR CONTACT INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 11435696 ↗
• InjuryJan 29, 2019Appropriate Device Problem Term/Code Not Available

  INFORMATION FROM THE SURGICAL OUTCOME SYSTEM WAS RECEIVED THAT THERE WAS AN INCIDENT WITH AN ARTHREX PRODUCT DURING A SHOULDER ARTHROSCOPY. IT WAS REPORTED THAT IT CAME TO COMPLICATIONS AND THE PATIENT HAD AN INFECTION AFTER SURGERY. A REVISION SURGERY IS REQUIRED TO REMOVE THE IMPLANT. THE PRIMARY SURGERY TOOK PLACE IN (B)(6) 2018 WITH AN ARTHREX MID SHAFT / CENTRAL THIRD PLATE FOR CLAVICLE FRACTURE. AT THE MOMENT WE DO NOT HAVE FURTHER INFORMATION. THE SURGEON WAS CONTACTED TO RECEIVE ALL THE NECESSARY INFORMATION TO EVALUATE THIS CASE. ON 08 JAN 2019 ADDITIONAL INFORMATION OBTAINED: THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2018. A OSTEOSYNTHESIS OF A FRACTURED COLLAR BONE WAS PERFORMED WITH DEVICE AR-2652CL. AS THERE WAS A LATE INFECTION OF THE IMPLANTED PLATE A REVISION SURGERY TOOK PLACE ON (B)(6) 2018 WHERE THE PLATE WAS REMOVED FROM THE PATIENT. ON 09 JAN 2019 ADDITIONAL INFORMATION OBTAINED: THE SURGEON HAS CONFIRMED THAT THIS WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM AND WAS BEING REPORTED AS A NON-PRODUCT RELATED ISSUE. THE SURGEON HAS STATED THE FOLLOWING TO THE SALES REP: THE INFECTION IS NOT RELATED TO THE PRODUCT. THE PLATE AND SCREWS ARE NON-STERILE DEVICES AN

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 8286727 ↗
• InjuryJul 25, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORIF OF LEFT CLAVICLE PROCEDURE ON (B)(6) 2018 WHERE AN AR-2652CL, LOT: UNK WAS IMPLANTED. ON (B)(6) 2018, AN INFECTION WAS NOTED ON HIS SKIN DURING HIS POST-OP VISIT. THE SURGEON ORDERED ANTIBIOTICS AND HAD CULTURES DONE. THE FACILITY IS CURRENTLY AWAITING THE RESULTS, HOWEVER, ACCORDING TO THE SURGEON, IT HAS COME BACK AS (B)(6). A REVISION SURGERY HAS NOT BEEN SCHEDULED AND IT IS UNKNOWN IF ONE WILL BE. THE FOLLOWING DEVICES WERE ALSO IMPLANTED DURING THE ORIF OF LEFT CLAVICLE PROCEDURE: AR-8835-14 3.5 CORTICAL SCREW 14MM X1, AR-8835-16 3.5 CORTICAL SCREW 16MM X2, AR-8835L-16 3.5 LOCKING SCREW 16MMX 3.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 7718876 ↗
• InjuryDec 7, 2016Break

  IT WAS REPORTED THAT THE PATIENT HAD AN ORIF CLAVICLE FX PROCEDURE PERFORMED ON (B)(6) 2016 WHICH WAS COMPLETED SUCCESSFULLY WITH A LEFT SS CENTRAL THIRD CLAVICLE FRACTURE PLATE ((B)(4)). AFTER THE PROCEDURE, WHILE THE PATIENT WAS DRIVING, HE FELT A POP WHICH WAS FOLLOWED BY PAIN AND SWELLING. THE PLATE BROKE IN HALF. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016. AT THAT TIME, THE BROKEN PLATE AND SCREWS WERE REMOVED FROM THE PATIENT. ANOTHER LEFT SS CENTRAL THIRD CLAVICLE FRACTURE PLATE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IN THE PROCESS OF REMOVING THE PLATE, THE SURGEON ALSO REMOVED THE FOLLOWING SCREWS: 3.5MM X 8MM SS LOW PROFILE SCREW ((B)(4)), 3.5MM X 12MM TM SS CORTICAL LOW PROFILE SCREW ((B)(4)), 3.5MM X 18MM SS TM CORTICAL LOW PROFILE SCREW ((B)(4)), 3.5MM X 12MM SS LOW PROFILE LOCKING SCREW ((B)(4)), 3.5MM X 14MM SS LOW PROFILE LOCKING SCREW ((B)(4)), 3.5MM X 18MM SS LOW PROFILE LOCKING SCREW ((B)(4)). BONE QUALITY: GOOD.

  Patient problems: Pain; Swelling

  MAUDE report 6150581 ↗