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U.S. Department of Health and Human Services

Class 3 Device Recall InterGro PLUS

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  Class 3 Device Recall InterGro PLUS see related information
Date Initiated by Firm October 15, 2007
Date Posting Updated February 14, 2008
Recall Status1 Terminated 3 on September 25, 2008
Recall Number Z-0618-2008
Recall Event ID 45469
510(K)Number K031399  
Product Classification Bone Filler (Calcium) - Product Code MQV
Product InterGro PLUS; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: DBM002, DBM005, DBM010, DBMW05 & DBMW10, Interpore Cross International, a Biomet company (lnterGro DBM products contain human tissue (allograft bone) and are intended for transplantation)
Code Information Serial Numbers: 600107, 600015, 279540, 6000098, 255137, 600550, 600232, 600199, 600180, 279579, 600125, 600126, 600201, 600339, 217530, 783490, 600365, 728840, 608430, 608440, 219980, 882050, 203995, 079160, 788840, 687010, 135970, 247877, 600113, 827220 & 247906 .
Recalling Firm/
Manufacturer
Interpore Cross International Inc
181 Technology Dr
Irvine CA 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
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 1,256
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = INTERPORE CROSS INTL.
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