Medical device manufacturer, DePuy Synthes, has issued a medical device alert concerning the following products:
The manufacturer is initiating a voluntary removal of the affected products due to potential damaged packaging. Investigation conducted by the manufacturer of the nine complaints they had received determined that product packaging may be compromised, which may present a potential for sterile barrier integrity failure.
According to the manufacturer, damaged packaging could impact the seal and result in a sterility breach. Implantation of potentially contaminated product could lead to infection and pain. If presence of polyurethane residue is not detected intraoperatively, and is left in patient, this may potentially impair range of motion in a rotating platform construct; or, cause an inflammatory reaction.
The manufacturer advised affected users to return all affected products.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 2 March 2021