TC-PLUS Solution Tibial Component-- Symmetric
FDA device recall Z-0017-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Plus Endoprothetik AG
- Reason for recall
- Labeling/packaging mix-up.
- Action taken
- Firm notified implanting surgeons by letter and telephone on May 16, 2003 and on June 2, 2003. One physician was contacted on August 26, 2003. The firm communicated the need to follow-up with the patients . Recall is complete.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 15
- Distribution
- TX, CA, VA, ID, NY, UT, FL
- Date initiated
- 2003-04-17
- Date posted
- 2003-10-15
- Date terminated
- 2003-12-03
- Location
- Rotkreuz, Switzerland
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 |