D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.

The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.

On 02/21/2019 the firm issued a recall notice to affected consignees. The recall notification informed the consignees of the following: Customers should immediately remove all identified products and contact TSI to receive an RMA and shipping instructions. 2. Contact information for returns: Name: Nicole Burrell or Val Saucedo Telephone: 713 726-0886 Email address: custservice@ tedansurgica.com Fax 713 726-0846 In addition, if you have distributed the identified product to end users, immediately identify all customers and notify them of this product recall in writing using the enclosed information. Your assistance is appreciated and necessary to prevent any possible injury to patients. Also as needed provide to these customers the attached recall response form for their completion and provide to TSI the name, address, and contact information for those customers. Other TSI distraction screws not identified as part of this recall may be used. However, as a precaution, always follow the instructions for use and carefully inspect sterile packaging for any breaches. If breaches are identified DO NOT USE THE PRODUCT and contact TSI immediately.