Class 3 Device Recall Mitek Products

• Date Initiated by Firm: June 16, 2003
• Date Posted: July 15, 2003
• Recall Status: Terminated on October 22, 2003
• Recall Number: Z-1005-03
• Recall Event ID: 26503
• 510(K)Number: K982662
• Product: Profile 8 x 20 mm Cannulated Interference Screw Round Head; Catalog Number: 230420
• Code Information: Lot Number: 0207146 Exp 2007-7
• Recalling Firm/ Manufacturer: Mitek Worldwide; 249 Vanderbuilt Drive; Norwood MA 02063
• For Additional Information Contact: James Kinney; 800-356-4385
• Manufacturer Reason for Recall: Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 X 25mm
• FDA Determined Cause: Other
• Action: Mitek notified consignees by letter on 6/16/0 by US Mail Certified Return Receipt. The international affiliates were notified by email on 6/16/03. Users were requested to return product in inventory.
• Quantity in Commerce: 40
• Distribution: CA, FL, NJ, MO, NY, OR, TX, VA Foreign: Argentina, Australia, Japan, Arab Emirates, Portugal, spain

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 = and Original Applicant = DEPUY ORTHOPAEDICS, INC.