FDA
TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY.
Indicated for use in the retraction of soft tissue away from the operative surface.
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
On 12/17/2015 the firm sent Recall Notification Letters to their customers. The letter identified the product, problem, and actions to be taken by the customer.