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U.S. Department of Health and Human Services

Class 2 Device Recall GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT

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 Class 2 Recall
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT
see related information
Date Posted December 04, 2013
Recall Status1 Open
Recall Number Z-0446-2014
Recall Event ID 66333
Premarket Notification
510(K) Number
K032295 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Code Information Batch No. 12GT20822
Recalling Firm/
Manufacturer
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis, Tennessee 38116
For Additional Information Contact Joe Metzger
901-396-2121 Ext. 5373
Manufacturer Reason
for Recall
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action Smith & Nephew sent an Urgent Recall Notification letter dated August 27, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. They were instructed to cease use and distribution of the product and quarantine for return. Customers were instructed to contact Smith & Nephew via email at FieldActions@smith-nephew.com or fax 901-566-7975 to obtain a return authorization (RA) number. Customers with questions were also instructed use this email address. Customers with affected product were instructed to return it along with the completed inventory Return Certification Form to the address listed on the form. Non-responding consignees were notified again on September 27, 2013, by email. For questions regarding this recall call 901-396-2121.
Quantity in Commerce 80 pieces
Distribution Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = SMITH & NEPHEW, INC.
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