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U.S. Department of Health and Human Services

Class 2 Device Recall GENESIS(R) II, NONPOROUS TIBIAL BASE, SIZE 6, RIGHT

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 Class 2 Recall
GENESIS(R) II, NONPOROUS TIBIAL BASE, SIZE 6, RIGHT
see related information
Date Posted November 01, 2013
Recall Status1 Open
Recall Number Z-0131-2014
Recall Event ID 66545
Premarket Notification
510(K) Number
K951987 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
Code Information Batch No. 13GM09505
Recalling Firm/
Manufacturer
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis, Tennessee 38116
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Joe Metzger
978-749-1330
Manufacturer Reason
for Recall
Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Smith & Nephew sent an Urgent - Product Recall 1st Notification letter to all affected sales staff via email and FedEx on October 7, 2013. The hospital was notified by sales rep on October 9, 2013 and the notification letter was sent to the hospital via Fed Ex on October 11, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, discontinue use, quarantine affected products immediately and return to Smith & Nephew. Customers were asked to complete the attached Inventory Return Certification Form and fax to 901-566-7975.
Quantity in Commerce 4 units
Distribution USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
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 RICHARDS, INC.
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