Allogenix; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: 02-3110, Interpore Cross International, a Biomet company (Allogenix DBM products contain human tissue (allograft bone) and are intended for transplantation)
- Recall Initiated
- October 15, 2007
- Posted
- February 14, 2008
- Terminated
- September 25, 2008
- Recall Number
- Z-0619-2008
- Quantity
- 34
- Firm Location
- Irvine, CA
Reason for Recall
Unapproved Testing: Interpore Cross International was recently informed that one of its human tissue suppliers, LifeLink Tissue Bank ("LifeLink"), utilized unapproved diagnostic testing (HBsAg & HBc) on certain lots of distributed donor tissue instead of the FDA approved screening test. As a result, Interpore Cross International has initiated a recall on specific lots of products containing human
Distribution
Nationwide
Lot / Code Info
Serial Numbers: 079180 & 234760
Root Cause
Nonconforming Material/Component
Action Taken
The Recall Notification letters will be sent via commercial carrier (UPS) with signature for verification of receipt required on Friday October 26, 2007, to all consignees, including hospitals and sales representatives, which summarizes the recall details and instructs the consignee to contact Interpore Cross via mail or facsimile with the enclosed Customer Response form, and to immediately return the affected product.