Osteofil Allograft, 5cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida
FDA device recall Z-0699-06 · posted 2006-03-28 · Terminated
Recall details
- Recalling firm
- Regeneration Technologies, Inc.
- 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.
- Action taken
- Notification sent to all consignees by Fed Ex 10/14/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 55
- Distribution
- Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.
- Date initiated
- 2005-10-14
- Date posted
- 2006-03-28
- Date terminated
- 2012-08-07
- Location
- Alachua, FL
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