Medical device manufacturer, Tornier SAS issued a medical device safety alert concerning all lots of Aequalis Reversed II and Reversed Fracture impactors. The affected item numbers are MWD021, MWD023, MWD024, MWD025.
Following the identification of the disassociation of an impactor tip during a surgery, without any clinical consequences for the patient, Tornier reviewed the event and determined that a redesign of the instrumentation was warranted.
The manufacturer initiated a voluntary recall of the product. The recalled instruments will be replaced by a new design in the near future. In the interim, Tornier recommends assembling the humeral components and glenoid sphere according to the Surgical Technical Addendum attached with their field safety notice.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 August 2013