Class 3 Device Recall DePuy Mitek Bioknotless Anchor

• Date Initiated by Firm: February 17, 2006
• Date Posted: March 15, 2006
• Recall Status: Terminated on June 28, 2006
• Recall Number: Z-0610-06
• Recall Event ID: 34684
• 510(K)Number: K002639
• Product Classification: Fastener, Fixation, Biodegradable, Soft Tissue - Product Code MAI
• Product: Depuy Mitek Bioknotless Anchor with Ethibond Suture Ref No. 212728
• Code Information: Lot Number: 1358481 Exp Date: Nov 2008
• Recalling Firm/ Manufacturer: Depuy Mitek, a Johnson & Johnson Co.; 325 Paramount Dr; Raynham MA 02767-5199
• For Additional Information Contact: James Kinney; 508-828-2726
• Manufacturer Reason for Recall: The inserter shafts bend, as they were manufactured with a different stainless steel than specified.
• FDA Determined Cause: Other
• Action: Depuy Mitek notified consignees by letter dated 2/17/06 to request accounts return devices.
• Quantity in Commerce: 200 pieces
• Distribution: Nationwide
• 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 = MAI