Smith & Nephew Recalls Journey BCS Knee CoCr Femoral Components
Smith & Nephew is recalling Journey BCS Knee CoCr Femoral Components because registry data indicates the first-generation system has a revision rate over 1.5 times the class average.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (knee implant) with a reported revision rate significantly higher than the class average, indicating a risk of harm, but the source text does not report specific injuries, hospitalizations, or fatalities, nor does it classify the recall as FDA Class I.
Plain-English summary
Smith & Nephew, Inc. is recalling 10,792 units of Journey BCS Knee CoCr Femoral Components. The affected catalog numbers range from 74021210 to 74021229. The recall covers all lots of these specific components.
The recall is based on data from the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). These registries 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.
The products were distributed worldwide, including in the United States, Puerto Rico, Austria, the United Arab Emirates, Australia, Belgium, Canada, China, Switzerland, Germany, Denmark, Finland, France, Great Britain, India, Spain, Italy, the Netherlands, Portugal, Sweden, Venezuela, and South Africa. Consumers and healthcare providers should contact Smith & Nephew for further instructions regarding the recall.
The recalled product
- Product
- Journey 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
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 10,792
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Part of a larger recall action
This product is one of 3 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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