Smith & Nephew Recalls GENESIS II Tibial Punches Due to Size Defect
Smith & Nephew is recalling 5 units of GENESIS II 13 mm tibial punches because they are 2 mm smaller than the specified size.
What this means for you
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, and the defect is a dimensional deviation without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling one lot of GENESIS II 13 mm tibial punches (Reference 71440408). The recall involves 5 units of the product.
The recall is being conducted because the tibial punches are 2 mm smaller than the specified dimensions. This manufacturing deviation means the product does not meet the intended specifications for use.
The affected units were distributed internationally to the United Arab Emirates, Spain, and Mexico. Users of these medical devices should stop using the affected punches and contact Smith & Nephew for further instructions.
The recalled product
- Product
- smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 5
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)
- 15FM16181
Distribution
Distribution scope not specified by the agency.
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