3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Inte
FDA device recall Z-1433-2010 · posted 2010-04-26 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Affected product had incorrect color label which is a secondary visual indicator for sizing.
- Action taken
- Encore Medical, LP notified consignees by e-mail dated March 19, 2010. Consignees were requested to return the affected product to the firm. For further information, contact Encore Medical, LP at 1-888-838-3668.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 7 units
- Distribution
- Worldwide Distribution -- United States (UT, IA) and Germany.
- Date initiated
- 2010-03-19
- Date posted
- 2010-04-26
- Date terminated
- 2010-07-22
- 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 |
|---|---|---|
| 3D KNEE (K020114) | Encore Orthopedics, Inc. | 2002-07-12 |