Recall Z-1299-2008
LifeCell Corporation · initiated October 17, 2007
Product
AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine
Codes / lots: Lot Numbers: B06E02E; Exp 3/2008; B06E02F, Exp. 3/2008; B07C29B, Exp 2/2009; B07E14E, Exp 3/2009; B07G24B, Exp 5/2009; B07G24C, Exp 5/2009; B07G24E, Exp. 5/2009; and B07G24F, Exp 5/2009.
Reason for recall
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)
FDA-determined cause: Release of Material/Component prior to receiving test results
Action taken
Consignee was notified by telephone, followed by a Recall letter sent by FAX on October 17, 2007 requesting return of any unused product.
Details
- Recall number
- Z-1299-2008
- Initiated
- October 17, 2007
- Posted by FDA
- March 26, 2008
- Terminated
- May 14, 2008
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Quantity
- 110 kits
- Distribution
- All syringe assemblies were distributed to Stryker Orthopaedics, Mahwah, NJ.
- Recalling firm
- LifeCell Corporation, Somerville, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1298-2008 | AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell…Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for… | 10/17/2007Terminated |