Smith & Nephew recalls specific knee prosthesis models due to labeling errors that could lead to incorrect use. Affected units have mixed labels indicating different sizes or types.
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 (JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6) because it was mislabeled. This confusion could lead to using the wrong size or type of implant, potentially causing complications during surgery or after implantation.
The product was mislabeled with incorrect size or type information. This could lead to using the wrong implant during surgery or after implantation, which might cause improper fitting or complications.
Patients who received this specific knee prosthesis model during surgery are likely affected. Surgeons and medical staff who handled the product during the recall period may also be at risk.
Check for the product code 'JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262' on the implant. The UDI/DI number 00885556178010 and batch number 22BM18348 are also specific identifiers for this recall.
Look for the product code 'JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262' and UDI/DI number 00885556178010 on the implant.
The product was mislabeled with incorrect size or type information, which could lead to using the wrong implant during surgery or after implantation.
Check for the product code 'JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262' and UDI/DI number 00885556178010 on the implant.
The recall does not specify a remedy, so no action is required unless you have the specific product code and UDI/DI number.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0157-2024 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0157-2024 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.
