EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Dist
FDA device recall Z-0009-2008 · posted 2007-10-10 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.
- Action taken
- Firm notified consignees regarding recall via letter on 08/09/07. Consignees informed that Encore customer service representatives would be contacting them to exchange recalled units with replacements.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HRY
- Quantity affected
- 5 units.
- Distribution
- Products distributed to direct accounts in CA, FL and MD.
- Date initiated
- 2007-08-09
- Date posted
- 2007-10-10
- 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 |
|---|---|---|
| UNI KNEE (K022437) | Encore Medical L.P. | 2002-08-23 |
| UNICONDYLAR KNEE (K020741) | Encore Orthopedics, Inc. | 2002-06-04 |