3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
FDA device recall Z-1213-2013 · posted 2013-05-02 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.
- Action taken
- The firm sent their US customer a "Urgent Field Safety Notice" letter on April 1, 2013. The letter explained the product problem and provided recommended actions as well as customer contact numbers.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- OIY
- Quantity affected
- 5
- Distribution
- US Distribution to the state of California and International Distribution to the country of Venezuela.
- Date initiated
- 2013-04-01
- Date posted
- 2013-05-02
- Date terminated
- 2013-07-01
- 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 |
|---|---|---|
| HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 (K091956) | Encore Medical L.P. | 2010-09-28 |