www.fdanews.com/articles/199136-smith-nephew-recalls-suture-based-repair-systems
Smith & Nephew Recalls Suture-Based Repair Systems
September 21, 2020
Smith & Nephew has released an urgent field safety notice advising users of a manufacturing problem that could have affected the sterility of its suture-based repair systems.
The company said the packaging issue may have caused a faulty or incomplete seal of the pouch surrounding the sterile product, affecting lots shipped between June 20, 2018, and Aug. 19, 2020.
Smith & Nephew said physicians should maintain their normal patient follow-up protocols for used sutures but said any unused devices should be returned to a company agency or distributor.