Arthrex® AR-7258-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867286481), received between Apr 17, 2024 and Jun 1, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. 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.

• MalfunctionJun 1, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON THE STICKER OF THE PRODUCT, INSTEAD OF THE LOT NUMBER, IT IS NOTED THE REFERENCE WITH AN EXPIRY DATE OF 31/03/2024 WHICH CORRESPONDS BY DEDUCTION TO THE LOT 100001 IN THE DEPOSIT OF THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19441937 ↗
• MalfunctionApr 17, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THERE IS A LABELING PROBLEM. THE REFERENCE OF THE DEVICE IS WRITTEN INSTEAD OF THE LOT NUMBER. IN FRONT OF THE LOT IT IS WRITTEN AR-7258-1 INSTEAD OF 100001. THE ESTABLISHMENT WAS NOT ABLE TO KNOW THE RIGHT LOT NUMBER TO TRACE ON THE PATIENT. THE PROBLEM WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127296 ↗