Smith & Nephew recalls specific knee prostheses due to mislabeling that could lead to incorrect use. Affected models include JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262. Contact for details.
The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
Smith & Nephew is recalling a specific knee prosthesis model due to mislabeling between two similar products. This could lead to using the wrong part, which might cause improper fitting or complications during surgery.
The prosthesis was mislabeled between two similar products. One was labeled as a constrained insert but packaged as an un-constrained insert, and vice versa. This could lead to using the wrong type of knee implant during surgery, potentially causing improper fitting or complications.
Patients who received the JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262 knee prosthesis from Smith & Nephew. Surgeons and medical staff who used this model during procedures are most at risk.
Check for the product name 'JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left' with reference number 74029262. The batch number is 22BM17564 and the UDI/DI code is 00885556176467.
Verify the product name, reference number, and batch number to confirm if your knee prosthesis is affected.
The recall is for mislabeling that could lead to using the wrong prosthesis during surgery, but it does not pose an immediate risk to patients who have already received the implant.
Check for the product name 'JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left' with reference number 74029262 and batch number 22BM17564.
The recall does not specify a remedy, so contact Smith & Nephew directly for guidance.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0158-2024 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0158-2024 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.
