OsteoPack 3 FZ 22cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
FDA Recall Z-0491-06 · 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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.