Z-0619-2008

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

Name: Z-0619-2008 Allogenix; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: 02-3110, Interpore Cross...
Creator: Interpore Cross International Inc
Published: 2007-10-15
License: https://open.fda.gov/license/

Interpore Cross International Inc / initiated 2007-10-15 / Terminated / root cause: manufacturing process

FDA source

Interpore Cross International Inc began a recall of Allogenix; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: 02-3110, Interpore Cross International, a Biomet company (Allogenix DBM products... on 2007-10-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0619-2008
Status: Terminated
Initiated: 2007-10-15
Posted: 2008-02-14
Terminated: 2008-09-25
Recalling firm: Interpore Cross International Inc
Product: 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)
Product code: MQV Filler, Bone Void, Calcium Compound
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 34
Distribution: Nationwide
Product codes and lots: Serial Numbers: 079180 & 234760

Product code MQV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)