medical Class II Updated 2022-07-27

Smith & Nephew, Inc. recalls (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Pro

Recalled Product

(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.

Hazard / Issue

The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product #71420186 - Lot #21DM14954S, exp. October 2030, UDI #03596010206350. Product #71420166 - Lot #21FM13870A, exp. October 2030, UDI #03596010206268.
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