Recall Z-1298-2008 ยท MQV Filler, Bone Void, Calcium Compound
LifeCell Corporation
AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine
| Date | Mar 26, 2008 (initiated Oct 17, 2007) |
| Status | Terminated |
| Reason | Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for HBsAG and HBcAB (later re-testing with FDA-approved donor screening test found samples non-reactive for both Hepatitis B Surface Antigen and Hepatitis B Core IgM/IgG Antibody) |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | Consignee was notified by telephone, followed by a Recall letter sent by FAX on October 17, 2007 requesting return of any unused product. |
| Quantity | 46 kits |
| Distribution | All syringe assemblies were distributed to Stryker Orthopaedics, Mahwah, NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052735 | ALLOCRAFT DBM Lifecell Corp., Dec 28, 2005 |