FDA Recall
Terminated
TC-PLUS Solution Tibial Component-- Symmetric
Recall: Z-0017-04
·
Initiated April 17, 2003
Recall
- Recall Number
- Z-0017-04
- Event Number
- 26326
- Firm
- Plus Endoprothetik AG Erlenstrasse 4b Rotkreuz Switzerland
- FEI Number
- 3002807898
- Status
- Terminated
- Root Cause
- Other
- Initiated
- April 17, 2003
- Posted
- October 15, 2003
- Terminated
- December 3, 2003
Description
TC-PLUS Solution Tibial Component-- Symmetric
Reason
Labeling/packaging mix-up.
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.
Distribution
TX, CA, VA, ID, NY, UT, FL
Quantity
15