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
- Company
- Smith & Nephew Inc
- Recall Initiated
- June 13, 2018
- Posted
- October 1, 2018
- Recall Number
- Z-0002-2019
- Quantity
- 42,050 units
- Firm Location
- Memphis, TN
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.
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.
Lot / Code Info
All lots
Root 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.