Knee prosthesis component mislabeled with swapped product identification
Smith & Nephew is recalling 29 units of a knee prosthesis component due to labeling and packaging errors where two product types were swapped during manufacturing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a risk-of-harm product where implantation of the wrong knee prosthesis component could cause serious injury. The FDA classified this as Class II, indicating potential for serious adverse consequences. No illnesses or injuries are reported in the recall notice.
Plain-English summary
Smith & Nephew, Inc. is recalling the JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left (REF 74029262), a knee prosthesis component, due to manufacturing and labeling errors.
The issue involves a product swap during laser etching, labeling, and packaging. One product type (XLPE ART ISRT) was labeled and packaged with the identification of another type (CNSTRD ART ISRT), and vice versa. This mislabeling could result in implantation of an incompatible prosthesis component.
The recall affects 29 units that were distributed worldwide, including throughout the United States and Japan. The affected batch number is 22BM17564 (UDI/DI 00885556176467).
Consumers and healthcare providers who have this product should contact Smith & Nephew, Inc. immediately to report possession of the device and obtain guidance on replacement or verification of the correct product.
The recalled product
- Product
- JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 29
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 00885556176467
- Batch Number 22BM17564
Distribution
Distributed nationwide across the United States.
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.
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