3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.
FDA device recall Z-2244-2010 · posted 2010-08-22 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing.
- Action taken
- Firm notified their consignees by letter on June 28, 2010.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 18
- Distribution
- Florida, Missouri, and Italy
- Date initiated
- 2010-06-28
- Date posted
- 2010-08-22
- Date terminated
- 2010-10-04
- 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 |