Arthrex® AR-7523Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867298002), received between May 18, 2021 and Apr 13, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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. How this data works · Data updated Oct 13, 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 13, 2026Failure to Advance

  ON 23-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-7523 MINI SUTURE TAPE MENISCUS REPAIR NEEDLE WOULD NOT ADVANCE PAST THE CURVE OF AN AR-7900 ZONENAVIGATOR SYSTEM HANDLE. THE ISSUE WAS DISCOVERED DURING A MENISCAL REPAIR PROCEDURE PERFORMED ON (B)(6) 2026. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 25-MAR-2026: WHEN THE AR-7900 ZONENAVIGATOR SYSTEM HANDLE FAILED, THE CANNULA WAS REPLACED WITH AN AR-7905 ZONE NAVIGATOR SYSTEM CANNULA; HOWEVER, THE NEEDLE STILL COULD NOT BE PASSED. THEREFORE, THE CASE WAS COMPLETED USING OTHER PRODUCT BY CONVERTING TO AN OUTSIDE-IN APPROACH. THE PROCEDURE WAS DELAYED BY APPROXIMATELY FIVE TO TEN MINUTES AS MULTIPLE METHODS WERE ATTEMPTED TO PASS THE NEEDLE THROUGH THE CANNULA. NO ADDITIONAL ANESTHESIA WAS BELIEVED TO HAVE BEEN ADMINISTERED TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 01-APR-2026: THE PATIENT DID NOT EXPERIENCE A TEMPORARY IMPAIRMENT OR SIGNIFICANT INCREASE IN RECOVERY TIME AS A RESULT OF SWITCHING TO AN OUTSIDE APPROACH. AN INCISION WAS ALREADY PRESENT FOR DEALING WITH THE HARDWARE PORTION OF THE TIBIA PLATEAU FRACTURE.

  Patient problems: Insufficient Information

  MAUDE report 24858871 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT AN INFECTION AFTER HE WAS TREATED WITH THE DEVICES AR-7900 (LOT: 10822462), AR-7910L (LOT: 928497924) AND AR-7523 (LOT: 934399472). THIS WAS NOTICED AFTER THE SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 11842456 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT AN INFECTION AFTER HE WAS TREATED WITH THE DEVICES AR-7900 (LOT: 10822462), AR-7910L (LOT: 928497924) AND AR-7523 (LOT: 934399472). THIS WAS NOTICED AFTER THE SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 11842353 ↗