Class 2 Device Recall Selex M2A Magnum Modular Head, 40 mm

• Date Initiated by Firm: September 13, 2011
• Date Posted: April 23, 2012
• Recall Status: Terminated on February 21, 2013
• Recall Number: Z-1449-2012
• Recall Event ID: 60595
• 510(K)Number: K062997
• Product Classification: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
• Product: Ref, S331140 Selex M2A Magnum Modular Head, 40 mm head diameter plus 3 mm neck,1 Taper, Sterile, Biomet Orthopedics, Warsaw, IN Product Usage: Intended for use in non-cemented primary and revision hip joint replacement
• Code Information: Part S331140, Lot 446970
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 574-267-6639 Ext. 1676
• Manufacturer Reason for Recall: Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Biomet contacted consignees with device inventory by telephone on September 13, 2011 requesting all associated product be quarantined immediately. An Urgent Medical Device Recall Notice was sent via U.S. mail March 23, 2012 to consignees with directions to immediately locate, discontinue use of the affected product and return to Biomet. The letter instructed consignees to carefully follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. The notification letter to consignees contained directions to confirm receipt of notice by calling 800-348-9500, extension 3983 or 3009. Questions concerning recall are directed to 574-372-3983 or 574371-3009 M-F 8 A.M. to 5 P.M. (ET).
• Quantity in Commerce: 5 devices
• Distribution: USA Nationwide Distribution including the states of: MI, NC., OK and WI.
• 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.

• 510(K) Database: 510(K)s with Product Code = LZO