FIBERGRAFT BG Putty 78000110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00856879006731), received between Feb 9, 2023 and Apr 28, 2026 — classified as 1 injury, 1 malfunction.

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

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 18, 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.

• MalfunctionApr 28, 2026Chemical Problem

  IT WAS REPORTED THAT FIBERGRAFT BG PUTTY LARGE 11CC WAS UNUSABLE AS IT WAS HARDENED WITHIN THE SYRINGE UPON OPENING DURING AN INTRAOPERATIVE EVENT. THE EVENT OCCURRED DURING A PROCEDURE FOR FEMUR NON-UNION. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED ISSUE, AS ANOTHER PRODUCT WAS OPENED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES OR IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015044 ↗
• InjuryFeb 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO THE MANUFACTURER ON (B)(6) 2023 THAT A PATIENT COMPLAINED THEY COULD FEEL SOMETHING HARD UNDER THE SKIN. ADDITIONAL INFORMATION WAS PROVIDED ON JANUARY 30, 2023 INDICATING THAT SECONDARY SURGERY WAS PERFORMED TO EXPLORE AND REMOVE THE PRODUCT FROM THE SOFT TISSUE. THE SURGEON ALSO STATED THAT THE PATIENT HAD A PALPABLE, PAINFUL MASS THAT CORRELATED WITH THE PRODUCT IN THE SOFT TISSUE ON THE LATERAL CALCANEUS. BASED ON THE INFORMATION PROVIDED BY THE SURGEON, IT WAS DETERMINED THAT THIS EVENT SHOULD BE REPORTED.

  Patient problems: Implant Pain

  MAUDE report 16341499 ↗