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U.S. Department of Health and Human Services

Class 2 Device Recall CERCLAGE WIRE

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  Class 2 Device Recall CERCLAGE WIRE see related information
Date Initiated by Firm June 28, 2010
Date Posted August 10, 2010
Recall Status1 Terminated 3 on January 23, 2012
Recall Number Z-2197-2010
Recall Event ID 56187
Product Classification cerclage, fixation - Product Code JDQ
Product CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, 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: 10DM13784
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 2		 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 1 unit
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.
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