TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
FDA device recall Z-0126-06 · posted 2005-11-03 · Terminated
Recall details
- Recalling firm
- Plus Orthopedics USA
- Reason for recall
- Labeling discrepancy.
- Action taken
- Firm retrieved the unit from the consignee and returned it to the manufacturer. Firm indicates that Operations contacted the agent site and requested the return.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1 unit
- Distribution
- NY
- Date initiated
- 2005-02-22
- Date posted
- 2005-11-03
- Date terminated
- 2007-02-05
- 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 |
|---|---|---|
| TC-PLUS SOLUTION KNEE (K000666) | Plus Orthopedics | 2000-10-13 |