Class 2 Device Recall HT XDRIVE SCREW

• Date Initiated by Firm: July 11, 2008
• Date Posted: November 04, 2008
• Recall Status: Terminated on September 11, 2009
• Recall Number: Z-0282-2009
• Recall Event ID: 50113
• 510(K)Number: K001238
• Product Classification: Screw - Product Code JEY
• Product: HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
• Code Information: Lot 493200
• Recalling Firm/ Manufacturer: Biomet Microfixation, Inc.; 1520 Tradeport Dr; Jacksonville FL 32218-2480
• For Additional Information Contact: 904-741-4400
• Manufacturer Reason for Recall: The packaging for the 91-2416, 2.4X16MM HT X-DRIVE SCREW, Lot 493200 actually contained the 99-6577, 2.0X7MM FOSSA X-DRIVE SCREW.
• FDA Determined Cause: Labeling mix-ups
• Action: An "Urgent Medical Device Recall Notice" was sent to customers on 07/11/2008 by certified letter. The letter described the problem, the risk and asked that customers discontinue use of the product and return them to Biomet. Also, customers were provided with a Inventory Reconciliation sheet and asked to fax it back to Biomet. Please contact Biomet Microfixation at 1-800-874-771 or 904-741-4400, ext. 448 for assistance.
• Quantity in Commerce: 10
• Distribution: Nationwide and 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.

• 510(K) Database: 510(K)s with Product Code = JEY and Original Applicant = WALTER LORENZ SURGICAL, INC.