Arthrex® AR-600-012SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867036628), received between Feb 16, 2026 and Feb 16, 2026 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 16, 2026Break

  IT WAS REPORTED THAT DURING A KNEE PROSTHESIS (TOTAL KNEE REPLACEMENT) SURGERY THE OUTER TEETH OF THE SAW BLADES AR-600-012S (LOT: 089328) BROKE OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344736 ↗
• MalfunctionFeb 16, 2026Break

  IT WAS REPORTED THAT DURING A KNEE PROSTHESIS (TOTAL KNEE REPLACEMENT) SURGERY THE OUTER TEETH OF THE SAW BLADES AR-600-012S (LOT: 089328) BROKE OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344643 ↗