Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
smith&nephew Recalled by Smith & Nephew, Inc. Due to The screws package with devices within lot 14AAP6352A...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Smith & Nephew, Inc. directly.
Affected Products
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, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. 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 (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.
Quantity: 28 units
Why Was This Recalled?
The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.
Where Was This Sold?
This product was distributed to 5 states: CO, IL, NJ, NY, TX
About Smith & Nephew, Inc.
Smith & Nephew, Inc. has 220 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report