Smith & Nephew Legion Knee Wedge Recalled for Incorrect Screw Size
Smith & Nephew is recalling 10 units of the Legion L-Wedge Size 4 because they contained 5MM screws instead of the required 10MM screws.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical implant where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Smith & Nephew, Inc. is recalling 10 units of the Legion L-Wedge, 10 MM DIS X 5 MM POS, Size 4, Screw-on Femoral Wedge (Ref 71421733). The recall is due to a manufacturing error where the devices contained 5MM screws instead of the required 10MM screws.
The affected product is identified by Lot Number 14GSM0440A. The devices were distributed in the US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, and Thailand. These components are indicated for use in revision knee surgery for conditions such as rheumatoid arthritis, post-traumatic arthritis, and osteoarthritis.
Healthcare providers and patients should stop using the affected devices and contact Smith & Nephew for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomi
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 10
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)
- Lot Number 14GSM0440A
Distribution
Distributed in 1 state:
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