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U.S. Department of Health and Human Services

Class 2 Device Recall LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT

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  Class 2 Device Recall LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT see related information
Date Initiated by Firm November 04, 2014
Date Posted December 12, 2014
Recall Status1 Terminated 3 on August 22, 2019
Recall Number Z-0590-2015
Recall Event ID 69759
510(K)Number K060742  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis

Usage:orthopedic.

Code Information Lot Numbers: 14EM16708, 14EM21988, 14DM22269
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Joe Metzger
978-749-1330
Manufacturer Reason
for Recall		 The stem taper on this device is undersized; the gauge point is not deep enough.
FDA Determined
Cause 2		 Process control
Action The firm, Smith & Nephew, Inc., sent an "Urgent-Product Recall 1st Notification-Urgent" letter dated 11/4/ 2014 to its customers via E-mail on 11/4/2014. International distributors were notified on 11/4/2014 by Email. Non-responding consignees will be contacted on 11/25/2014 by original method. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect your inventory and locate any unused devices and immediately quarantine; complete and return the Inventory Return Certification Form via fax to: +1-901-566-7975, even if you do not have product to return; contact Smith & Nephew's Safety Affairs Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain return authorization (RA) number; and return affected product to Smith & Nephew, Attn: Global Field Actions, 3303 E Holmes Road, Memphis, TN 38118. If you have any questions, please contact the Group Director, Quality Assurance +1-901-399-1970.
Quantity in Commerce 45 units
Distribution Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.
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 = JWH and Original Applicant = SMITH & NEPHEW, INC.
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