Smith & Nephew Recalls Mispackaged Genesis II Tibial Base Components
Smith & Nephew is recalling four units of Genesis II tibial base components due to size and side mislabeling.
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: The recall is classified as FDA Class II, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The hazard is a mislabeling error regarding size and side, which is a significant labeling issue but does not involve a high-risk pathogen or structural defect.
Plain-English summary
Smith & Nephew Inc is recalling four units of the GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, REF 71420168. The recall is due to a packaging error where the size 5 left component was mis-packaged as size 6 right, and vice versa.
The affected units were distributed nationwide in the states of Arizona, North Carolina, Iowa, Pennsylvania, Ohio, Maryland, and Tennessee. The specific batch number for the recalled items is 13GM11272.
Healthcare providers and patients should stop using the affected components and contact Smith & Nephew for instructions on how to return the product.
The recalled product
- Product
- GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
- Manufacturer
- Smith & Nephew Inc
- Hazard
- Affected units
- 4
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 (1)
- Batch No. 13GM11272
Distribution
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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