BIOSURE 72204402Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885554036787), received between Dec 3, 2020 and Feb 11, 2026 — 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.

• MalfunctionFeb 11, 2026Fracture

  IT WAS REPORTED THAT, DURING A TIBIAL FIXATION WITH ACL RECONSTRUCTION, THE SURGEON INSERTED ONE (1) SCREW BIOSURE REGENESORB AND SUBSEQUENTLY ENGAGED THE IMPLANT WITH AN INCORRECT SCREWDRIVER. THIS RESULTED IN THE SCREW FRACTURING WHILE FULLY DEPLOYED IN THE PATIENT. THE PROXIMAL PORTION OF THE SCREW WAS REMOVED WITH THE SCREWDRIVER; HOWEVER, THE DISTAL PORTION REMAINED LODGED IN SITU. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, AND A CHANGE IN SURGICAL TECHNIQUE USING A STAPLE AS SECONDARY FIXATION. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24316955 ↗
• InjuryNov 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A SCREW BIOSURE REGENESORB BROKE OFF WHEN BEING INSERTED INTO TIBIA FOR GRAFT FIXATION EVEN AFTER SURGEON TAPPED BEFORE INSERTING SCREW. SURGEON WAS ABLE TO REMOVE THE PROXIMAL HALF OF THE SCREW WITH A BIOSURE DRIVER, AND LEFT THE DISTAL HALF REMAINING IN THE TIBIAL TUNNEL SINCE HE WASN'T ABLE TO REMOVE IT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. THE CURRENT HEALTH STATUS OF THE PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800795 ↗
• InjuryDec 3, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIOSURE SCREW BROKE WHEN IT WAS BEING THREADED INTO THE PATIENT. 60% OF THE SCREW WAS REMOVED WITH A GRASPER AND THE OTHER DISTAL 40% REMAINED ON THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10939683 ↗

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.