Smith & Nephew Recalls Legion Knee Prosthesis Due to Undersized Stem Taper
Smith & Nephew is recalling 24 units of the Legion COCR Constrained Femoral Component because the stem taper is undersized and the gauge point is not deep enough.
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. Per the rubric, a Class II recall involving a risk-of-harm product where injury has not yet been reported is assigned a score of 3 (High).
Plain-English summary
Smith & Nephew, Inc. is recalling 24 units of the Legion COCR Constrained Femoral Component, Size 4, Left (Reference 71425004). The recall is due to a manufacturing defect where the stem taper on the device is undersized and the gauge point is not deep enough.
The affected devices, identified by Lot Number 14FM05730, were distributed nationwide in the United States, specifically in Michigan, Minnesota, Missouri, Ohio, Pennsylvania, Iowa, and Tennessee. The devices were also distributed internationally to Switzerland, Canada, Colombia, Germany, Dubai (UAE), Thailand, South Africa, South Korea, and Singapore.
Consumers and healthcare providers who have purchased or received these specific knee prosthesis components should contact Smith & Nephew for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 24
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 14FM05730
Distribution
Part of a larger recall action
This product is one of 3 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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