UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm
FDA device recall Z-0540-05 · posted 2005-02-15 · Terminated
Recall details
- Recalling firm
- Plus Orthopedics
- Reason for recall
- Knee tibial insert is mislabeled completely as different device.
- Action taken
- PLUS Orthopedics QA department has identified a labeling eror on Article 0214703, affecting lot number 044843. This Ultra-congruent PE insert package may contain a Standard PE insert.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 10, 1 is implanted.
- Distribution
- California, Idaho, Illinois, Wisconsin, Oregon
- Date initiated
- 2005-01-04
- Date posted
- 2005-02-15
- Date terminated
- 2005-03-03
- 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 |
|---|---|---|
| VKS KNEE SYSTEM (K022204) | Plus Orthopedics | 2002-10-18 |