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U.S. Department of Health and Human Services

Class 2 Device Recall GENESIS(R) II, NONPOROUS TIBIAL BASE, SIZE 5, LEFT

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 Class 2 Device Recall GENESIS(R) II, NONPOROUS TIBIAL BASE, SIZE 5, LEFTsee related information
Date Initiated by FirmOctober 07, 2013
Date PostedNovember 01, 2013
Recall Status1 Terminated 3 on August 23, 2016
Recall NumberZ-0130-2014
Recall Event ID 66545
510(K)NumberK951987 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductGENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
Code Information Batch No. 13GM11272
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information ContactJoe 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		Process control
ActionSmith & 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 Commerce4 units
DistributionUSA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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