Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Smith&Nephew ENGAGE Cementless Partial Knee System Recalled by Smith & Nephew, Inc. Due to Recent complaint data indicates that the revision rate...
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 ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-10012-200, SIZE 2-LEFT MEDIAL; d) REF 1-10012-250, SIZE 2-RIGHT MEDIAL; e) REF 1-10012-300, SIZE 3-LEFT MEDIAL; f) REF 1-10012-350, SIZE 3-RIGHT MEDIAL; g) REF 1-10012-400, SIZE 4-LEFT MEDIAL; h) REF 1-10012-450, SIZE 4-RIGHT MEDIAL; i) REF 1-10012-500, SIZE 5-LEFT MEDIAL; j) REF 1-10012-550, SIZE 5-RIGHT MEDIAL; k) REF 1-10012-600, SIZE 6-LEFT MEDIAL; l) REF 1-10012-650, SIZE 6-RIGHT MEDIAL; Unicondylar knee prothesis
Quantity: 2146 units
Why Was This Recalled?
Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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