Arthrex® AR-7288RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867392038), received between Jul 15, 2024 and Jul 15, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA PHONE AND EMAIL THAT QTY. 4 OF AN AR-7288R RADIOPAQUE FT STERNAL W/CUTTING NDL HAD AN ISSUE BEFORE USE IN AN UPCOMING PROCEDURE SCHEDULED LATER THAT DAY AND HAD EXPIRED. AN ADDITIONAL EMAIL WAS RECEIVED FROM THE SALES REPRESENTATIVE, PROVIDING ADDITIONAL INFORMATION AFTER THREE OF THE EXPIRED AR-7288R RADIOPAQUE FT STERNAL W/CUTTING NDL HAD BEEN USED IN A CABG PROCEDURE ON (B)(6) 2024. WHEN THE FIRST IMPLANT WAS OPENED, THE NEEDLE HAD PULLED OFF THE SUTURES BEFORE USE, SO ANOTHER AR-7288R WAS OPENED. UPON CHECKING, IT WAS NOTICED THAT ALL FOUR AR-7288R HAD EXPIRED. THE SALES REPRESENTATIVE INFORMED THE SURGEON AND THE NURSES OF THE EXPIRED PRODUCT AND THAT HE BELIEVED IT TO BE AN ERROR WITH THE LABELING. THE SURGEON AND NURSES UNDERSTOOD, AND THREE AR-7288R STERNAL CLOSURES AND TWO AR-7289R STERNAL CLOSURES WERE SUCCESSFULLY IMPLANTED. LATER THAT DAY, THE DIRECTOR OF THE FACILITY REQUESTED PAPERWORK CONFIRMING THAT THESE PRODUCTS WERE MISLABELED. ADDITIONALLY, IT WAS NOTED THAT A DISPOSABLE TENSIONER WAS ALSO USED, AND THEY HAD A FEW ISSUES GETTING THE RIGHT FRICTION TO APPLY ON THE TAPES AROUND THE SQUARE, BUT ADEQUATE TENSION WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19739681 ↗