Plus Endoprothetik AG
TC-PLUS Solution Tibial Component-- Symmetric
| Date | Oct 15, 2003 (initiated Apr 17, 2003) |
| Status | Terminated |
| Reason | Labeling/packaging mix-up. |
| Root cause | Other |
| Action | 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. |
| Quantity | 15 |
| Distribution | TX, CA, VA, ID, NY, UT, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000666 | TC-PLUS SOLUTION KNEE Plus Orthopedics, Oct 13, 2000 |