Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA. The CuttingEdge acetabular reamers are used to ream the acetabulum and prepare the bone for the insertion of the shell during hip arthroplasty. Surgical procedures for shells used with CuttingEdge instruments indicate that reaming should begin with a Spherical Reamer that is 4mm smaller than the templated or gauged size of the planned shell. Per the procedures, reaming should increase in size by 1mm increments until final sizing is achieved. Surgical judgment is used to assess bone stock, bone quality, desired level of press fit, and proper amount of reaming.

A 46mm acetabular reamer was lasermarked as a 44m reamer and distributed to the field.

Stryker sent an "URGENT PRODUCT RECALL" letter dated December 29, 2011 to all affected customers. Notification letters and Product Accountability Forms were sent to Stryker accounts via FedEx on January 3, 2012 with return receipt. Hospital Risk Management and Chief of Orthopaedics Notification letters and Product Recall Acknowledgement Forms were sent on January 10, 2012. Surgeon Notification letters and Product Recall Acknowledgement Forms were sent on January 10, 2012. Notification sent via e-mail toCanada.EMEA, LatinAmerica.Asia Pacific on December 23, 2011. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to return the affected product. A Product Recall Acknowledgment Form was attached to the letter for customers to complete and return. Contact the firm at 201-972-2100 for questions regarding this recall.