Smith & Nephew Recalls Legion Hemi Step Tibial Wedge Due to Packaging Error
Smith & Nephew is recalling 12 units of Legion Hemi Step Tibial Wedges because they were inadvertently packaged with an incorrect screw component.
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 involves a packaging error (incorrect screw component) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling 12 units of the LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT (REF 71423432). The recall is due to a packaging error where the affected products were inadvertently packaged with an incorrect screw component.
The constrained knee systems are designed for use in patients in primary and revision surgery where the posterior cruciate ligament and one or both of the collateral ligaments are absent or incompetent. The affected units were distributed to France, Germany, the Netherlands, Norway, and Switzerland.
No specific instructions for consumers are provided in the source text, as the distribution was limited to foreign countries. The recall is classified as Class II by the FDA.
The recalled product
- Product
- LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral…
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 12
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)
- 13KSL0038C
Distribution
Distribution scope not specified by the agency.
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