TC-PLUS Solution Tibial Component-- Symmetric
This recall has been terminated (originally issued October 15, 2003).
- Recall Initiated
- April 17, 2003
- Posted
- October 15, 2003
- Terminated
- December 3, 2003
- Recall Number
- Z-0017-04
- Quantity
- 15
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling/packaging mix-up.
Distribution
TX, CA, VA, ID, NY, UT, FL
Lot / Code Info
Lot 0211.13.4553
Root Cause
Other
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.