BIOSURE 72204406Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885554036824), received between Jan 14, 2022 and Aug 22, 2024 — classified as 2 injuries, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K142948); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SCREW BIOSURE WAS DAMAGED. ALL FRAGMENTS WERE RETRIEVED FROM THE TIBIA ANTERIOR SIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035749 ↗
• InjuryFeb 8, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL ARTHROSCOPY PROCEDURE, WHEN THE PHYSICIAN WAS INSERTING A BIOSURE REGENESORB SCREW TO FIXATE AN ACL GRAFT IN THE TIBIA, HE DRILLED A 9.5 DIAMETER TUNNEL AND HAD A SIZE 9 GRAFT. A 9MM SCREW WAS OPENED AND ON INSERTION, USING THE CORRECT BIOSURE DRIVER THE SCREW STARTED TO BREAK. ON NOTICING THEY STOPPED USING THIS SCREW AND INSTEAD USED A BIOSUREPK SCREW, THE SAME SIZE WITHOUT ANY ISSUES, ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO DELAY REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13483208 ↗
• InjuryJan 14, 2022Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BIOSURE SCREW BROKE WHILE INSERTING IT INTO TIBIAL TUNNEL. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261544 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142948. 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.