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U.S. Department of Health and Human Services

Class 2 Device Recall GENESIS II NONPOROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT

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  Class 2 Device Recall GENESIS II NONPOROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT see related information
Date Initiated by Firm August 01, 2017
Create Date August 22, 2018
Recall Status1 Terminated 3 on February 19, 2019
Recall Number Z-2883-2018
Recall Event ID 80752
510(K)Number K951987  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
Code Information Lot Numbers: 16CMB0061A, 16CMB0066A
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact
901-396-2121
Manufacturer Reason
for Recall		 Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
FDA Determined
Cause 2		 Employee error
Action The firm notified its consignees of the problem and the recall by email on 08/01/2018. The firm requested the return of the product.
Quantity in Commerce 27 units
Distribution Australia, Austria, Germany, Great Britain, Poland, Spain
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 RICHARDS, INC.
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