Arthrex® AR-9501-10PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867250420), received between Mar 6, 2025 and Apr 17, 2025 — classified as 1 injury, 1 malfunction.

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

• MalfunctionApr 17, 2025Material Separation; Material Separation

  IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 36 UNIVERS REVERS CA HUMERAL HEAD ADAPTER AND A CA HUMERAL HEAD DISENGAGED FROM AN AR-9502F-39CPC ARTHREX UNIVERS REVERS SUTURECUP AND HUMERAL STEM. THEN, THE 36 UNIVERS REVERS CA HUMERAL HEAD ADAPTER AND THE CA HUMERAL HEAD COULD NOT BE TAKEN APART. SIZING WAS THOUGHT TO BE AN ISSUE, SO THE SURGEON ATTEMPTED TO ENGAGE A 39 SUTURECUP AND AN AR-9502-39ARCA 39 HUMERAL HEAD ADAPTER ON THE BACK TABLE, BUT THEY KEPT COMING APART. THE CASE WAS COMPLETED USING A 36 HUMERAL HEAD ADAPTER. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2025. THIS ISSUE ADDED AN ADDITIONAL HOUR AND A HALF TO THE CASE WHICH ALREADY NEEDED A TIME LIMIT DUE TO THE PATIENT'S HEALTH AND WAS AT A HIGHER RISK FOR SURGERY. AT THIS TIME, IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. ADDITIONAL INFORMATION WAS RECEIVED ON 3/31/2025: THE SALES REPRESENTATIVE PROVIDED THE PART NUMBER AR-9501-10P FOR THE ARTHREX UNIVERS REVERS HUMERAL STEM, AR-9550-19RCA FOR THE ARTHREX UNIVERS REVERS CA HUMERAL HEAD, AND AR-9556-22RCA UNIVERS REVERS CA HUMERAL HEAD. THE AR-9501-10P FOR THE ARTHREX UNIVERS REVERS HUMERAL STEM WAS NOT EXCHANGED AND WAS THE SAME

  Patient problems: Insufficient Information

  MAUDE report 21861130 ↗
• InjuryMar 6, 2025Positioning Failure; Positioning Failure

  ON 02/14/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE FOLLOWING ARTHREX PARTS (QTY. 2) OF AN AR-9502-42ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 42, AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 39, AR-9556-22RCA UNIVERS REVERS CA HUMERAL HEAD 56/22, AR-9502F-42CPC ARTHREX UNIVERS REVERS SUTURE CUP, 42, AR-9502F-39CPC ARTHREX UNIVERS REVERS SUTURE CUP, 39 (NEUTRAL), AR-9501-10P ARTHREX UNIVERS REVERS HUMERAL STEM, SIZE 10 WERE UNSUCCESSFUL IN SEATING THE 42 ADAPTER INTO THE 42 CUP. A 39 ADAPTER AND A 39 CUP WERE ALSO ATTEMPTED BUT UNSUCCESSFUL IN PROPERLY SEATING. NOTHING BROKE INSIDE THE PATIENT. THE PROCEDURE WAS ABORTED. THIS WAS DISCOVERED DURING A REVISION REVERSE SHOULDER PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536568 ↗