Reficio DBM Putty 1cc 27800218Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849777008761), received between Nov 3, 2022 and Nov 3, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K130498); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2022Component Missing; Component Missing

  THE MANUFACTURER WAS MADE AWARE OF AN ALLEGED MEDICAL DEVICE GRAFT COMPLAINT ON 10/05/2022. IT WAS REPORTED THAT A MEDICAL DEVICE GRAFT DISTRIBUTED WAS IDENTIFIED AS HAVING EMPTY GRAFT PACKAGING AT AN END USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721566 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130498. One submission often covers many models, so check the product and lot details in each record.

• Z-1526-2020 · May 3, 2019 · Terminated
  OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Produc