Smith & Nephew recalls a specific knee implant model due to a package containing the wrong size (3 left instead of 4 left) as labeled. This could lead to improper fitting and potential complications.
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Smith & Nephew is recalling a specific knee implant model because a package was shipped with the wrong size (size 3 left instead of size 4 left) as labeled. This mismatch could cause improper fitting and potential complications for users.
The hazard occurs because the package contained a size 3 left implant instead of the size 4 left as labeled. This mismatch could lead to improper fitting of the implant, potentially causing complications during surgery or after implantation.
Individuals who own or use the specific Smith & Nephew knee implant model with reference number 71421163 are affected. Those who received the implant with the wrong size (size 3 left instead of size 4 left) are at higher risk.
Check if your implant has the reference number 71421163 and is labeled as size 3 left. The product description includes a UDI/DI code 03596010543820 and batch number 23LM00479.
Verify the reference number and size on your implant label to confirm if it matches the recalled model (reference 71421163, size 3 left).
The recall was initiated because a package contained a size 3 left implant instead of the size 4 left as described on the product label.
Check your implant label for the reference number 71421163 and size 3 left. If it matches, contact Smith & Nephew for further instructions.
The recall indicates a potential for improper fitting due to the wrong size, but no specific injuries were reported. The risk level is low.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0277-2025 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0277-2025 from Smith & Nephew. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.