Smith & Nephew Recalls Mispackaged Genesis II Knee Prosthesis Components
Smith & Nephew is recalling two lots of Genesis II knee prosthesis components because they were packaged with the wrong size and side.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a packaging error (wrong size/side) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Smith & Nephew, Inc. is recalling two lots of Genesis II Non-Porous Cruciate Retaining Femoral Components. The recall involves 27 units of Size 6 Right components that were incorrectly packaged with Size 4 Left components.
The affected products are identified by Lot Numbers 16CMB0061A and 16CMB0066A. These components were distributed to Australia, Austria, Germany, Great Britain, Poland, and Spain.
Healthcare providers and patients should verify the size and side of the implanted or pending components against the packaging to ensure the correct product is used. If a mismatch is identified, contact Smith & Nephew for instructions on replacement or removal.
The recalled product
- Product
- GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 27
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)
- Lot Numbers: 16CMB0061A
- 16CMB0066A
Distribution
Distribution scope not specified by the agency.
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