Class 2 Device Recall IMHS CP

• Date Initiated by Firm: January 22, 2009
• Date Posted: August 04, 2009
• Recall Status: Terminated on August 18, 2011
• Recall Number: Z-1704-2009
• Recall Event ID: 52177
• Product Classification: IM hip screw guide pin - Product Code LXH
• Product: IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.
• Code Information: Lot Number: 08K22270
• Recalling Firm/ Manufacturer: Smith & Nephew Inc; 1450 E. Brooks Rd; Memphis TN 38116
• For Additional Information Contact: Victor Rocha; 901-396-2121 Ext. 5373
• Manufacturer Reason for Recall: Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long.
• FDA Determined Cause: Process design
• Action: Urgent Medical Device Recall letter dated January 23, 2009. All affected Smith & Nephew Sales Representatives, Distributors and Hospitals were notified of problem and the recall via Fed Ex and e-mail on 01/22/2009. They were instructed to immediately check their inventory and return the product.
• Quantity in Commerce: 99 units
• Distribution: Distribution to USA, Switzerland and Australia.
• 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.