Smith & Nephew Recalls JOURNEY BCS Knee Polyethylene Inserts
Smith & Nephew is recalling JOURNEY BCS Knee Conventional Polyethylene Inserts 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 where specific injury or death has not been explicitly reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Smith & Nephew, Inc. is recalling JOURNEY BCS Knee Conventional Polyethylene Inserts. The recall covers 64,642 units distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The recall was initiated 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 received these implants should contact their healthcare provider for further evaluation and guidance.
The recalled product
- Product
- JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 7402313
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 64,642
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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