BIOSURE 72204403Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885554036794), received between Aug 31, 2019 and Apr 3, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionApr 3, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING THE SET UP FOR A PATELLAR TENDON TECHNIQUE PROCEDURE, THE STERILE BAG OF A SCREW BIOSURE REGENESORB WAS BROKEN WHEN OPENING IT. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE AND THERE WAS NO DELAY REPORTED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16668205 ↗
• InjuryJun 10, 2021Break; Break

  IT WAS REPORTED THAT DURING BTB ACL RECONSTRUCTION PROCEDURE INSIDE THE PATIENT, THE SCREW BIOSURE REGENESORB 9MM X 20MM BROKE DURING THE INSERTION PROCEDURE. ALL PIECES WERE REMOVED FROM THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT BY SUCTION. THE PROCEDURE WAS FINISHED WITH ANOTHER SIZE OF BIOSURE REGENESORB. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975847 ↗
• MalfunctionAug 31, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE SURGERY THE SCREW CRACKED WHILE THE SURGEON WAS INSERTING IT. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. SURGERY WAS FINISHED USING A COMPETITOR DEVICE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT'S ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8952879 ↗

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.