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Terminated

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)

FDA Recall Z-0619-2008 · Posted 2008-02-14

Recalling FirmInterpore Cross International Inc
Recall StatusTerminated
Product CodeMQV
Date Initiated2007-10-15
Date Terminated2008-09-25
Product Quantity34

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

Firm Action

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

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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