PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision S
FDA device recall Z-1610-2014 · posted 2014-05-13 · Terminated
Recall details
- Recalling firm
- Ortho Development Corporation
- Reason for recall
- A femoral component containing pegs was found in a box for the pegless version.
- Action taken
- Ortho notified customers via email and phone calls on April 1, 2014. Customers were asked to return product in inventory.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 5
- Distribution
- US Nationwide Distribution in the states of NV, and AZ.
- Date initiated
- 2014-04-01
- Date posted
- 2014-05-13
- Date terminated
- 2014-07-14
- Location
- Draper, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHO DEVELOPMENT BALANCED KNEE SYSTEM (K994370) | Ortho Development Corp. | 2000-03-24 |