Smith & Nephew Recalls Legion PS Knee Inserts Due to Packaging Error
Smith & Nephew is recalling 29 Legion PS High Flex XLPE Articular Inserts because they were packaged with an incorrect part.
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, but the source text indicates a packaging error (incorrect part) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling 29 units of the LEGION PS High Flex XLPE size 5-6 9mm Articular Insert. The recall was initiated because the product was packaged with an incorrect part.
The affected product is identified by Lot Number 19FM12500 and Product Number 71453221. The units were distributed in the United States to Tennessee, North Carolina, California, Oregon, New Mexico, Texas, Pennsylvania, Michigan, Louisiana, Delaware, and Illinois. International distribution included Italy, the Netherlands, Romania, and Puerto Rico.
This is a Class II recall. Consumers and healthcare providers should stop using the affected inserts and contact Smith & Nephew for further instructions.
The recalled product
- Product
- LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 29
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 (2)
- Lot Number 19FM12500
- Product Number 71453221.
Distribution
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