Class 2 Device Recall Low Profile SelfTapping Bone Screw,

• Date Initiated by Firm: March 10, 2011
• Date Posted: May 03, 2011
• Recall Status: Terminated on February 17, 2012
• Recall Number: Z-2135-2011
• Recall Event ID: 58325
• 510(K)Number: K991807
• Product Classification: Starter, bone screw - Product Code HWD
• Product: Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box 587, Warsaw, IN 46581 USA. STERILE.; To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.
• Code Information: Part: 103532, Lot: 427460; and Part: 103533, Lot: 502360.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582
• For Additional Information Contact: 574-371-3755
• Manufacturer Reason for Recall: One lot of 30 mm screws was switched with one lot of 25 mm screws.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Biomet Orthopedics sent an Urgent Medical Device Recall Notice letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove the affected lots from their inventory, and return them to Biomet. Complete and enclosed FAX Back Response Form to 574-372-1683 prior to return of product. Distributors were instructed to notify all sub-accounts of the recall. Confirm receipt of notice by calling, 800-348-9500, extension 3755 or 3983. For questions regarding this recall call 574-372-3983, Monday through Friday, 8AM to 5PM.
• Quantity in Commerce: 100
• Distribution: Worldwide Distribution - USA including CA, GA, IA, IL, IN, KS, KY, MD, MI, MN, MO, NC, ND, NJ, NY, OK, PA, SD, TX, VA, WA, and WI and the country of Japan.
• 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 = HWD and Original Applicant = BIOMET, INC.