Smith & Nephew, Inc. is recalling 57 units of JOURNEY II BCS knee prosthesis articular inserts because the products were laser etched, labeled, and packaged incorrectly. Two different types of inserts—the XLPE Articular Insert and the Constrained Articular Insert—were swapped during the manufacturing process, meaning the physical device in the package does not match the label. This recall involves the JOURNEY II BCS Articular Insert (Size 5-6, Left 10 MM) and the JOURNEY II BCS Constrained Articular Insert (Size 5-6, Left 10 MM) distributed globally, including in the United States and Japan.
If a surgeon implants a mislabeled insert, the device may not provide the intended level of stability or range of motion required for the patient's specific knee anatomy. This could lead to premature wear of the implant, joint instability, or the need for a revision surgery to replace the incorrect component.
Manufacturer notification and product return.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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