Recall Z-0618-2008 ยท MQV Filler, Bone Void, Calcium Compound
Interpore Cross International Inc
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)
| Date | Feb 14, 2008 (initiated Oct 15, 2007) |
| Status | Terminated |
| Reason | 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 | 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 | 1,256 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031399 | INTERGRO DBM Interpore Cross Intl., Feb 18, 2005 |