Recall Z-1965-2009 ยท MQV Filler, Bone Void, Calcium Compound
Theken Spine LLC
iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.
| Date | Sep 3, 2009 (initiated Aug 26, 2008) |
| Status | Terminated |
| Reason | Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04. |
| Root cause | Error in labeling |
| Action | Theken Spine, LLC contacted the Consignee August 26, 2008 via telephone and instructed them to inventory their stock and return affected product to the firm. For further questions, contact Theken Spine, LLC at 1-330-475-8662. |
| Quantity | 22 units |
| Distribution | Nationwide Distribution -- TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040134 | THERILINK BONE VOID FILLER Therics, Inc., Mar 9, 2004 |