UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004 Femoral Component Size 4, 26006 Femoral Component Size 6,
FDA device recall Z-0191-2007 · posted 2006-11-16 · Terminated
Recall details
- Recalling firm
- Plus Orthopedics USA
- Reason for recall
- There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component.
- Action taken
- The depth of the withdrawal action taken in June, 2003 was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.
- Root cause
- Other
- Status
- Terminated
- Product code
- HRY
- Quantity affected
- 68
- Distribution
- California
- Date initiated
- 2006-07-18
- Date posted
- 2006-11-16
- Date terminated
- 2007-12-13
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM (K982859) | Plus Orthopedics | 1999-07-30 |