Class 3 Device Recall InterGro PLUS

• Date Initiated by Firm: October 15, 2007
• Date Posted: February 14, 2008
• Recall Status: Terminated 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: 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