BIOSURE 72204400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885554036763), received between Nov 16, 2020 and Aug 16, 2023 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE BIOSURE SCREW BROKE WHEN IT WAS INSERTED INTO THE BONE TUNNEL OF THE FEMUR SIDE. ALL THE BROKEN PIECES WERE REMOVED WITH FORCEPS. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS NORMAL AND WAS SINCE DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561040 ↗
• MalfunctionNov 16, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE SCREW WAS TURNED AWAY WHEN THE SCREW WAS TURNED IN, IT BROKE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10848119 ↗

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.