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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 Device Recall GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERTsee related information
Date Initiated by FirmAugust 27, 2013
Date PostedDecember 04, 2013
Recall Status1 Terminated 3 on August 20, 2019
Recall NumberZ-0446-2014
Recall Event ID 66333
510(K)NumberK032295 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductGENESIS(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 TN 38116
For Additional Information ContactJoe 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		Package design/selection
ActionSmith & 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 Commerce80 pieces
DistributionWorldwide 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 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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