Recall Z-0002-2019

Smith & Nephew, Inc. · initiated June 13, 2018

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149

Codes / lots: All lots

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: Other

Action taken

The 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.

Details

Recall number
Z-0002-2019
Initiated
June 13, 2018
Posted by FDA
October 1, 2018
Product code
JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Quantity
42,050 units
Distribution
Worldwide 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.
Recalling firm
Smith & Nephew, Inc., Memphis, TN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0001-2019 Class IIJourney BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212…The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian… 06/13/2018Open, Classified
Z-0003-2019 Class IIJOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113…The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian… 06/13/2018Open, Classified