Smith & Nephew Recalls Legion Hemi Stepped Tibial Wedges Due to Incorrect Screws
Smith & Nephew is recalling 8 units of Legion Hemi Stepped Tibial Wedges because the included screws were too long to properly affix the device.
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, and the source text describes a packaging error (incorrect screw length) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Smith & Nephew, Inc. is recalling 8 units of the LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/RT-MDL (REF 71421147). The recall was initiated after a complaint indicated that the tibial wedge screws packaged with the wedge were too long. These screws are intended to affix the wedge to the tibial baseplate.
The affected units were distributed in the states of Tennessee, Wisconsin, Ohio, and Kansas, as well as in Belgium, Germany, and the United Kingdom. The specific lot code for the recalled items is 14KM16422.
Consumers and healthcare providers should stop using the affected tibial wedges and contact Smith & Nephew for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 8
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)
- 14KM16422
Distribution
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