Smith & Nephew Recalls Journey BCS Oxinium Knee Femoral Components
Smith & Nephew is recalling Journey BCS Oxinium knee femoral components due to elevated revision rates reported in international joint registries.
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 is classified as FDA Class II. The hazard involves a medical device with elevated revision rates, which represents a risk of harm requiring re-operation, but the source does not report specific injuries, deaths, or hospitalizations, placing it in the High severity category.
Plain-English summary
Smith & Nephew, Inc. is recalling the JOURNEY BCS OXINIUM Knee Femoral Components, including catalog numbers 74021110 through 74021149. The recall involves 42,050 units that were distributed worldwide, including the United States, Puerto Rico, and various international markets.
The recall is being conducted because data from the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and the 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.
Patients who have had these components implanted should contact their orthopedic surgeon to discuss the findings and determine if further evaluation or intervention is necessary.
The recalled product
- 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, 7402113
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 42,050
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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