FDA Device

TC-PLUS Solution Tibial Component-- Symmetric

Hazard

Labeling/packaging mix-up.

What You Should Do

Remedy

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.

Products

TC-PLUS Solution Tibial Component-- Symmetric
Brand
Plus Endoprothetik AG Erlenstrasse 4b Rotkreuz Switzerland
UPC
Lot 0211.13.4553

Units Affected

15