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U.S. Department of Health and Human Services

Class 3 Device Recall Allogenix;

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 Class 3 Recall
Allogenix;
see related information
Date Posted February 14, 2008
Recall Status1 Terminated on September 25, 2008
Recall Number Z-0619-2008
Recall Event ID 45469
Premarket Notification
510(K) Number
K031399 
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
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)
Code Information Serial Numbers: 079180 & 234760
Recalling Firm/
Manufacturer
Interpore Cross International Inc
181 Technology Dr
Irvine, California 92618-2402
For Additional Information Contact Kathleen Ideo
949-453-3200 Ext. 104
Manufacturer 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
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = INTERPORE CROSS INTL.
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