BIOSURE 72204396Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885554036725), received between May 27, 2019 and Dec 17, 2020 — 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.

• MalfunctionDec 17, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE SCREW BROKE WHEN IT WAS BEING SCREWED IN THE PATIENT. SCREW WAS REMOVED. THERE WAS AN UNKNOWN DELAY AND IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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

  MAUDE report 11027976 ↗
• MalfunctionMay 27, 2019Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE REGENESORB SCREW BROKE INTO PIECES. ALL FRAGMENTS WERE COMPLETELY REMOVED FROM THE PATIENT. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY. THE PATIENT WAS NOT STATED TO BE INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8644398 ↗

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.