Inserter for Titanium Elastic Nails (TEN), orthopedic device

potential for mechanical failures such as breakage.

Synthes sent an Urgent Notice: Medical Device Recall letter dated September 3, 2015, to all affected customers. The letter identified the product the problem and the action need to be taken by the customer. ACTIONS REQUIRED: We have record that your facility has received the product(s) subject to this recall. It is important to note that the removal of the product would prevent the performance of emergency surgery, thus DePuy Synthes is not requiring an immediate removal of affected product(s). DePuy Synthes has developed a replacement & recovery plan for indicated devices and replacement parts are becoming available. If you have questions on replacement timing and availability, please call DePuy Synthes at 1-800-479-6329. If you have questions regarding the return and recovery of the part, we ask that you contact your local DePuy Synthes Sales Consultant.