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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 PLUSsee related information
Date Initiated by FirmOctober 15, 2007
Date PostedFebruary 14, 2008
Recall Status1 Terminated 3 on September 25, 2008
Recall NumberZ-0618-2008
Recall Event ID 45469
510(K)NumberK031399 
Product Classification Bone Filler (Calcium) - Product Code MQV
ProductInterGro 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 ContactKathleen 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
ActionThe 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 Commerce1,256
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MQV
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