Arthrex® AR-12240FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867252493), received between Oct 19, 2021 and Apr 18, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE IS BROKEN. NO ADDITIONAL INFORMATION REGARDING A SPECIFIC FAILURE MODE WAS PROVIDED. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133138 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE IS BROKEN. NO ADDITIONAL INFORMATION REGARDING A SPECIFIC FAILURE MODE WAS PROVIDED. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133135 ↗
• MalfunctionOct 19, 2021Break

  IT WAS REPORTED THAT DURING MENISCAL RESECTION THE TIP BROKE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12658442 ↗