Knee Prosthesis Implant Recall: Wrong Size Component Shipped
Smith & Nephew is recalling a knee prosthesis component because packages were found to contain the wrong size implant. The size 3 left component was shipped instead of the size 4 left as labeled.
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: This is an FDA Class II medical device recall involving a documented product mix-up where the wrong implant size was shipped. While no illnesses or injuries have been reported to date, a wrong-size knee prosthesis poses a clear risk of surgical and medical complications. This meets the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Smith & Nephew Inc. is recalling a LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT (knee prosthesis implant), size 4 left, reference number 71421164. The recall affects 2 units that were distributed in the United States and internationally.
The issue was identified when a complaint was received indicating that a package labeled to contain a size 4 left component actually contained a size 3 left component instead. This is a packaging or product mix-up error that resulted in the wrong implant being shipped.
The affected devices were distributed in the United States (Texas) and internationally to Spain, France, and the United Kingdom. The batch number is 23LM03388 and the Universal Device Identifier (UDI/DI) is 03596010543837.
The recalled product
- Product
- smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
- Manufacturer
- Smith & Nephew Inc
- Category
- Medical Device — Joint Implant
- Hazard
- device-mix-up
- size-mismatch
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 (2)
- UDI/DI 03596010543837
- Batch Number 23LM03388
Distribution
Distribution scope not specified by the agency.
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