The Recall Desk
HighFDA (Devices)·Z-0278-2025·Announced 2024-11-06

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
Affected units
2

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

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 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.

See all 2 products in this recall →

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Same hazard · device mix up

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