UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6,
FDA device recall Z-0192-2007 · posted 2006-11-16 · Terminated
Recall details
- Recalling firm
- Plus Orthopedics USA
- Reason for recall
- The modified devices were distributed by Plus Orthopedics USA (Plus USA) June 10, 2003 prior to FDA approval to market of the modified device (Special 510(k) K032052, clearance date July 25, 2003) and withdrawn from the field June 25, 2003.
- 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
- 12
- Distribution
- California
- Date initiated
- 2006-07-18
- Date posted
- 2006-11-16
- Date terminated
- 2007-12-13
- Location
- San Diego, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UC-PLUS SOLUTION UNICONDYLAR KNEE (K032052) | Plus Orthopedics | 2003-07-25 |