Class 3 Device Recall DePuy Mitek

• Date Initiated by Firm: August 09, 2005
• Date Posted: November 18, 2005
• Recall Status: Terminated on May 02, 2006
• Recall Number: Z-0161-06
• Recall Event ID: 32951
• Product Classification: Orthopedic Manual Surgical Instrument - Product Code LXH
• Product: DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm Catalog Number : 232220
• Code Information: Lot Number: JBV04259
• Recalling Firm/ Manufacturer: Depuy Mitek, a Johnson & Johnson Co.; 325 Paramount Dr; Raynham MA 02767-5199
• For Additional Information Contact: Jim Kenney; 508-828-2726
• Manufacturer Reason for Recall: Mislabeled: The kit contained the incorrect Ligament Passer. The package contained a 9.5 mm instead of the labeled 11.5mm ligament passer
• FDA Determined Cause: Other
• Action: DePuy Mitek notified the accounts by US Mail on 8/09/05. Accounts were requested to return product.
• Quantity in Commerce: 5 boxes /10 units (50 pieces)
• Distribution: CA, NC, VA
• 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.