Class 2 Device Recall Arcos Modular Revision System Torque Limiting THandle

• Date Initiated by Firm: January 28, 2011
• Date Posted: March 07, 2011
• Recall Status: Terminated on July 27, 2011
• Recall Number: Z-1594-2011
• Recall Event ID: 57915
• Product Classification: Prosthesis, hip, semi-constrained (metal, uncemented acetabular component) - Product Code KWA
• Product: ARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850, Biomet Orthopedics Warsaw, IN. The torque limiting T-handle is used with attachments and hex drivers for preparation of the femur and for locking screw insertion at specified torque limit in Arcos hip procedures.
• Code Information: 419402, 419403, 419404 and 419405.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582
• For Additional Information Contact: Mary Johnson; 574-267-6639 Ext. 1676
• Manufacturer Reason for Recall: The firm received two complaints of the tabs on the Torque Limiting T-Handle fracturing during surgery. The firm performed internal testing and found that the tabs may fracture when used in the "OFF" or "locked" setting for hand-reaming the femoral canal.
• FDA Determined Cause: Device Design
• Action: Biomet, Inc. made telephone calls to distributor accounts on January 28, 2011, with specific instructions that the Arcos Torque Limiting T-Handle was not to be used in the "OFF" position. Distributors were required to use the Arcos Torque Limiting T-Handle on the "55" setting for insertion of locking screws and troch bolt. Biomet, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTICE letter dated February 21, 2011, to their distributors. The letter stated that the firm was currently manufacturing replacement handles which would be distributed to the field shortly. Consignees were advised to immediately discontinue use of the T-Handle in the "OFF" position. Send back the current T-Handle as soon as they receive a replacement. Carefully follow the instructions on the enclosed "FAX Back Response Form." Fax a copy of the Response Form to 574-372-1683 prior to return of product. Use priority carrier for shipment. If the product has been further distributed, consignees must notify hospital personnel of this action, via the enclosed "Dear Bioment Customer" notice. This letter must be give to hospital personnel responsible for receiving recall notices. Consignees are charged with the location and return of these products. Consignees were instructed to confirm receipt of this notice by calling, 800-348-9500, ext. 3755 or 3983. For any questions call 574-371-3755 or 574-372-3983.
• Quantity in Commerce: 40 units
• Distribution: Worldwide Distribution - USA including the states of CA, NY, FL, VA, UT, IL, MI, KY, OH, MA, PA, SD, MO, TX, NV, Puerto Rico, and the countries of Australia, New Zealand, Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.