BIOSURE 72201783Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010611796), received between Jul 25, 2023 and May 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K080358); they may or may not involve this specific model.

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.

• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BIOSURE HA SCREW BROKE DURING USE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986466 ↗
• MalfunctionJul 25, 2023Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR CRUCIATE LIGAMENT (PCL) PROCEDURE, WHEN THE BIOSURE HA SCREW WAS BEING INSERTED INTO THE TIBIAL TUNNEL, PIECES OF THE SCREW BROKE UPON INSERTION. THE SCREW AND THE LOOSE PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITH THE HELP OF FORCEPS. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE PREVIOUSLY PREPARED WITH A 9MM BIOSURE TAP. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393403 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080358. One submission often covers many models, so check the product and lot details in each record.

• Z-0957-2026 · Nov 24, 2025 · Open, Classified
  BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
• Z-1225-2012 · Feb 6, 2012 · Terminated
  Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue