Smith & Nephew Legion HK Femoral Wedge Recall Due to Incorrect Screw Size
Smith & Nephew is recalling Legion HK Femoral Wedge components because the included screws are 5 mm instead of 10 mm, making them too short for use.
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 corresponds to a moderate severity. The hazard is a dimensional defect (screws too short) that prevents proper use, but the source text does not report any injuries, illnesses, or deaths.
Plain-English summary
Smith & Nephew, Inc. is recalling 28 units of the Legion HK Femoral Wedge (Wedge and Screw), 5 mm, Size 5, Reference 71422159. The recall involves Batch Number 14AAP6352A. The product is a sterile, single-use medical device indicated for revision knee surgery in patients with specific arthritis conditions or failed prior surgeries.
The recall was initiated because the screws packaged with the devices in this specific lot are 5 mm in length instead of the required 10 mm. According to the source text, these 5 mm screws are too short to be used with the Legion HK Distal Wedge Size 5.
The affected units were distributed worldwide, including in the United States (New York, Illinois, New Jersey, Texas, Colorado) and in Belgium, Great Britain, Australia, Germany, the Netherlands, and Norway. Healthcare providers and patients should stop using these specific components and contact Smith & Nephew for further instructions.
The recalled product
- Product
- smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age,
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 28
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 Number14AAP6352A
Distribution
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