Smith & Nephew Recalls Swapped Genesis II Tibial Base Implants
Smith & Nephew is recalling four units of Genesis II tibial base implants due to packaging errors where size 5 left and size 6 right components were swapped.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a packaging error (swapped sizes) rather than a material defect or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
Smith & Nephew Inc is recalling four units of the Genesis II Non-Porous Tibial Base, Size 6, Right (Ref 71420188). The recall is due to a packaging error where a non-porous tibial base size 5 left was mis-packaged as size 6 right, and vice versa.
The affected units are identified by Batch No. 13GM09505. The products were distributed nationwide in the United States to the states of Arizona, North Carolina, Iowa, Pennsylvania, Ohio, Maryland, and Tennessee.
Healthcare providers and patients should check their inventory and records for this specific reference number and batch. If the product has been implanted, patients should contact their orthopaedic surgeon to discuss the potential implications of the size mismatch.
The recalled product
- Product
- GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
- Manufacturer
- Smith & Nephew Inc
- 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. 13GM09505
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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