Class 3 Device Recall Mitek Profile

• Date Initiated by Firm: February 28, 2003
• Date Posted: April 01, 2003
• Recall Status: Terminated on February 04, 2004
• Recall Number: Z-0698-03
• Recall Event ID: 25698
• 510(K)Number: K982662
• Product Classification: Screw, Fixation, Bone - Product Code HWC
• Product: Mitek Profile 7 x 25 mm Cannulated Interference Screw Round Head Product Reference No.: 230325
• Code Information: Lot Number.: 0301593
• Recalling Firm/ Manufacturer: Mitek Worldwide; 249 Vanderbilt Drive; Norwood MA 02062
• For Additional Information Contact: James Kenney; 781-251-3102
• Manufacturer Reason for Recall: Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 25 mm
• FDA Determined Cause: Other
• Action: Mitek Worldwide notified domestic accounts by US Mail on 2/28/03. The International affiliates were sent notifications by Federal Express on 2/28/03.
• Quantity in Commerce: 19
• Distribution: CO, FL, MN, PA, TX International- Mitek Affiliates: Australia, Columbia, Japan UK,
• 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 = HWC