Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
FDA Recall Z-0701-06 · Posted 2006-03-28
Recalling FirmRegeneration Technologies, Inc.
Recall StatusTerminated
Product CodeMQV
Date Initiated2005-10-14
Date Terminated2012-08-07
Product Quantity59
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 Fed Ex 10/14/2005.
Root Cause
Other
Distribution Pattern
Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.