Allogenix; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: 02-3110, Interpore Cross International, a Biomet

FDA device recall Z-0619-2008 · posted 2008-02-14 · Terminated

Recall details

Recalling firm

Interpore Cross International Inc

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

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MQV

Quantity affected

34

Distribution

Nationwide

Date initiated

2007-10-15

Date posted

2008-02-14

Date terminated

2008-09-25

Location

Irvine, CA