Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Osteofil Allograft Paste (Bio) of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

FDA Recall Z-0486-06 · Posted 2006-02-07

Recalling FirmRegeneration Technologies, Inc.
Recall StatusTerminated
Product CodeMQV
Date Initiated2005-10-14
Date Terminated2012-07-26

Reason for Recall

The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.

Firm Action

Notification sent to all consignees by FedEx. 10/14/2005

Root Cause

Other

Distribution Pattern

Products were distributed worldwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑