Class 2 Device Recall Depuy Mitek Fastin

• Date Initiated by Firm: October 27, 2005
• Date Posted: January 26, 2006
• Recall Status: Terminated on May 02, 2006
• Recall Number: Z-0446-06
• Recall Event ID: 33990
• 510(K)Number: K041075
• Product Classification: Fastener, Fixation, Biodegradable, Soft Tissue - Product Code MAI
• Product: Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture; Reference Number: 222740
• Code Information: Lot Number:1270449
• Recalling Firm/ Manufacturer: Depuy Mitek, a Johnson & Johnson Co.; 325 Paramount Dr; Raynham MA 02767-5199
• For Additional Information Contact: Kathryn L. Burroughs; 800-382-4682
• Manufacturer Reason for Recall: The device may contain one strand of suture instead of two strands
• FDA Determined Cause: Other
• Action: DePuy Mitek initiated the recall to domestic accounts by letter on 10/27/05 and to J & J Affiliates by email.
• Quantity in Commerce: 19 boxes (5 pieces each)
• Distribution: CA, IA, FL, MI, MO, OR, TX Foreign:Australia, Brazil, Sweden
• 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 and Original Applicant = DEPUY MITEK, A JOHNSON & JOHNSON COMPANY