iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.
FDA device recall Z-1965-2009 · posted 2009-09-03 · Terminated
Recall details
- Recalling firm
- Theken Spine LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 22 units
- Distribution
- Nationwide Distribution -- TX.
- Date initiated
- 2008-08-26
- Date posted
- 2009-09-03
- Date terminated
- 2012-03-09
- Location
- Akron, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THERILINK BONE VOID FILLER (K040134) | Therics, Inc. | 2004-03-09 |