VariLift Bone Plug w/ End Cap; 15mm Dia, 24mm long; Ref #: CIE1-15-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.
FDA device recall Z-0311-2008 · posted 2008-01-09 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- 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.....)
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- JDK
- Quantity affected
- 56 units.
- Distribution
- Nationwide: including direct accounts in CO, KS and TX.
- Date initiated
- 2007-09-19
- Date posted
- 2008-01-09
- Date terminated
- 2008-03-10
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OTI BONE CEMENT PLUG (K030608) | Osteoimplant Technology, Inc. | 2003-06-12 |