Arthrex® AR-600RZHRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867111066), received between Feb 11, 2021 and Oct 27, 2025 — classified as 6 malfunctions.

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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Break; Break

  ON 10/09/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-600RZH REAMER ATTACHMENT BROKE DURING A CASE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. PROCEDURE WAS COMPLETED BY SWITCHING TO NEW ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389842 ↗
• MalfunctionJun 19, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE AR-600 STOPPED WORKING AND LATER HEATED UP. THE AR-600RZH ALSO WOULD NOT GRIP INSIDE THE HANDPIECE. THE CASE WAS COMPLETED BY USING A NEW AR-600 AND A NEW AR-600RZH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566384 ↗
• MalfunctionJun 13, 2024Break; Break

  IT WAS REPORTED THAT THE AR-600RZH BROKE APART WHEN REAMING THE GLENOID.

  Patient problems: Insufficient Information

  MAUDE report 19532308 ↗
• MalfunctionJun 1, 2024Break; Break

  ON 04/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-600RZH REAMER ATTACHMENTS SPRING POPPED OUT. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19441917 ↗
• MalfunctionMay 24, 2024Break; Break

  IT WAS REPORTED THAT THE ATTACHMENT FELL APART DURING USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390280 ↗
• MalfunctionFeb 11, 2021Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE AR-600RZH, COMPLETELY BROKE OFF DURING THE CASE. THE CASE WAS COMPLETED BY USING ANOTHER AR-600RZH WITHOUT FURTHER ISSUE. NO PATIENT HARM .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314060 ↗