Arthrex® AR-9562-36NLRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867296732), received between Sep 16, 2020 and May 8, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2025Defective Device; Defective Device

  ON 04/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9562-36NL PERIPHERAL SCREW WAS RECEIVED DEFECTIVE WITH THE SCREW HEAD NOT FITTING THE PROPER HEX DRIVER. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984519 ↗
• InjuryMay 24, 2021Break

  IT WAS REPORTED THAT A REVERSE TOTAL SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE PRIMARY PROCEDURE TOOK PLACE ON (B)(6) 2020. SEE ATTACHED PRE-OPERATIVE X-RAYS IMAGES. THE FOLLOWING ARTHREX PRODUCT WAS EXPLANTED DURING THE REVISION SURGERY; AR-9502F-36CPC (LOT: 19.02550), AR-9503-3633-3 (LOT: 19.00009), AR-9560-24-2 (LOT: 6364), AR-9561-20S (LOT: 7039), AR-9562-36NL (LOT: 18.01681 / THIS SCREW WAS BROKEN), AR-9563-20 (LOT: 19.00617), AR-9563-24 (LOT: 2018005452), AR-9564-2433-LAT (LOT: 19.00014). THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE REVISION SURGERY; AR-9502F-36CPC (LOT: 19.04723), AR-9503S-03C (LOT: 19.00504).

  Patient problems: Insufficient Information

  MAUDE report 11872365 ↗
• InjuryMar 15, 2021Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO THE LOOSENING OF AN ARTHREX PROSTHETIC JOINT. THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2020. THE COMPLICATION WAS REPORTED ON (B)(6) 2020; INDICATING LOOSENING OF PROSTHETIC JOINT AND A REVISION REQUIRED. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021. THE FOLLOWING ARTHREX PRODUCT WAS EXPLANTED DURING THE REVISION SURGERY; AR-9560-24 (LOT: 5655). AR-9561-20P (LOT: 7038). AR-9562-36NL (LOT: 2018005757). AR-9562-40NL (LOT: 2018001457). AR-9563-20 (LOT: 2019003063). AR-9564-2436-LAT (LOT: 19.03388). AR-9502F-36RCPC (LOT: 19.00394). AR-9503S-06 (LOT: 170052510). THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE REVISION SURGERY; AR-9502F-36RCPC (LOT: 20.01053). AR-9555-06 (LOT: 170143213). AR-9503S-06 (LOT: 20.01369).

  Patient problems: Insufficient Information

  MAUDE report 11485323 ↗
• InjurySep 16, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT (B)(6) 2019 A PATIENT HAD A REVERSE SHOULDER PROCEDURE. ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION SURGERY. THE PATIENT HAD AN AUTOGRAFT TO THE GLENOID ON HER INITIAL SURGERY AND IT DID NOT APPEAR TO HAVE HEALED. THE SALES REPRESENTATIVE WHO WAS PRESENT DURING THE REVISION REPORTS THAT THE SURGEON HAD MENTIONED IN SURGERY THAT HE BELIEVED THAT THE LOCKING MECHANISM ON THE BASEPLATE MAY NOT HAVE BEEN FUNCTIONING APPROPRIATELY (THE SCREW WAS NOT LOCKED IN). DURING THE ORIGINAL PROCEDURE THE FOLLOWING ARTHREX DEVICES HAD BEEN IMPLANTED: AR-9564-2436-LAT, GLENOSPHERE, LOT 18.00689. AR-9503S-03, HUMERAL INSERT, LOT 18.00870 . AR-9502F-36CPC, UNIVERS REVERS SUTURE CUP, LOT 170141708 . AR-9561-25P, MODULAR CENTRAL POST, LOT 5368 . AR-9560-24-2, MODULAR BASEPLATE, LOT 5408. AR-9562-36NL, PERIPHERAL SCREW NON-LOCKING, LOT 2018001207. AR-9563-36, PERIPHERAL SCREW LOCKING, LOT 2018001490. AR-9563-40, PERIPHERAL SCREW LOCKING, LOT 2018001491. AR-9501-12P, UNIVERS REVERS HUMERAL STEM SIZE 12, LOT 170125705. DURING THE REVISION SURGERY ALL OFF THE ABOVE LISTED ORIGINAL IMPLANTS WERE EXPLANTED, EXCEPT FOR THE AR-9501-12P, UNIVERS REVERS HUMERAL STEM SIZE 12, WHICH WAS LE

  Patient problems: Impaired Healing

  MAUDE report 10540478 ↗