Class 2 Device Recall CERCLAGE WIRE

• Date Initiated by Firm: June 28, 2010
• Date Posted: August 10, 2010
• Recall Status: Terminated on January 23, 2012
• Recall Number: Z-2198-2010
• Recall Event ID: 56187
• Product Classification: cerclage, fixation - Product Code JDQ
• Product: CERCLAGE WIRE, 0.8 MM DIA. X 200 MM LENGTH, SST, REF 71163008, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, Germany Usage: Bone fracture fixation
• Code Information: Lot Number: 10DM08157
• 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: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.
• FDA Determined Cause: Process control
• Action: All affected Smith & Nephew Sales Representatives were notified of problem and the recall was sent via overnight mail on 01/23/2009. All affected Smith & Nephew International Distributors were notified via email and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return.
• Quantity in Commerce: 34 units
• Distribution: KY, TX, DC, NC, CA, AZ, GA and OH; 3 International: Australia, Malaysia, and Switzerland
• 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.