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U.S. Department of Health and Human Services

Class 2 Device Recall Journey BCS Knee System

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 Class 2 Device Recall Journey BCS Knee Systemsee related information
Date Initiated by FirmJune 13, 2018
Date PostedOctober 01, 2018
Recall Status1 Open3, Classified
Recall NumberZ-0001-2019
Recall Event ID 80313
510(K)NumberK042515 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductJourney BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Code Information All lots
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		The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.
FDA Determined
Cause 2		Other
ActionThe Field Safety Notice (FSN) sent to risk managers on 06/13/2018 asks customers to inspect inventory, locate and quarantine affected, unused Journey BCS Knee CoCr Femoral Components and JOURNEY BCS OXINIUM Knee Femoral Components. Affected product subject of the voluntary removal is to be returned to Smith & Nephew. All consignees are asked to complete an FSN Response Form, even if they do not have product to return. The Field Safety Notice, communicated with surgeons that these first generation JOURNEY BCS tibial inserts should only be used for polyethylene exchange revision of the first generation JOURNEY BCS total knee constructs where the femoral component and tibial baseplate are well-fixed. This notification, addressed to implanting surgeons, requesting their receipt and acknowledgement of the FSN.
Quantity in Commerce10,792 units
DistributionWorldwide distribution, including US nationwide and Puerto Rico, Austria, United Arab Emirates, Australia, Belgium, Canada, China, Switzerland, Germany, Denmark, Finland, France, Great Britain, India, Spain, Italy, Netherlands, Portugal, Sweden, Venezuela, South Africa.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JWH
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