Recall Z-0309-2008 ยท JDK Prosthesis, Hip, Cement Restrictor
Encore Medical, Lp
VariLift Bone Plug w/ End Cap; 11mm Dia, 24mm long; Ref #: CIE1-11-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.
| Date | Jan 9, 2008 (initiated Sep 19, 2007) |
| Status | Terminated |
| Reason | Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....) |
| Root cause | Labeling Change Control |
| Action | The recalling firm notified consignees of its recall via an Urgent Device Recall letter on 09/19/07. Consignees notified of a labeling error regarding device usage and were told they would be notified by a customer service rep to facilitate return of the recalled devices. |
| Quantity | 40 units. |
| Distribution | Nationwide: including direct accounts in CO, KS and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030608 | OTI BONE CEMENT PLUG Osteoimplant Technology, Inc., Jun 12, 2003 |