The safety notice said that the company identified a manufacturing issue in the product packaging process that could result in an improper or incomplete seal of the pouch surrounding the sterile product. If that happens, it could result in a breach of the sterile barrier created by the pouch.
In the most likely event, the company said. the pouch breach is identified prior to use and has no patient impact. However, the worst-case scenario could result in the pouch sterile barrier being breached and going undetected, deeming it unsterile and potentially leading to a biological response, such as infection. However, Smith + Nephew has not received any complaints for the worst case.
Affected lots of products including several parts and batches of the Osteoraptor and Healicoil suture anchors were shipped between June 20, 2018, and Aug. 19, 2020.
Smith + Nephew said that anyone affected by the warning must locate and quarantine all affected, unused devices, then return them to their national Smith + Nephew agency/distributor.