Washington, DC: Stryker Howmedica Osteonics Corp, in conjunction with the Food and Drug Administration (FDA) has issued a Class 2 recall of its Custom Straight Accolade, also known as Handles. The Handles are instruments that attach to the femoral rasps or broaches to prepare the Femoral Canal in total hip replacement procedures.
Stryker Orthopaedics has become aware that there is the potential for the above referenced instruments to fracture in two pieces along the width of the body under the striking plate.
Stryker Orthopaedics sent a Urgent Product Recall update dated August 18, 2011, via FedEx to all affected customers. The letter identified the product(s) the problem and the action needed to be taken by the customer.
106 units are affected as follows: All lots I-H08641400 CUSTOM STRAIGHT ACCOLADE I-H08641400 CUSTOM STRAIGHT ACCOLADE I-H08641400 CUSTOM STRAIGHT ACCOLADE I-H08641400 CUSTOM STRAIGHT ACCOLADE I-H1427HFOO.
