(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
Check against the official notice below — it lists the full affected range.
Smith & Nephew, Inc. is recalling 31 Genesis II Non-Porous Tibial Baseplate devices that were mispackaged with swapped contents. The affected devices are Genesis II Non-Porous Tibial Baseplate Size 5 Right (Product #71420186, Lot #21DM14954S) and Genesis II Non-Porous Tibial Baseplate Size 4 Left (Product #71420166, Lot #21FM13870A), both with expiration dates of October 2030. In these cases, the devices inside the inner tray do not match the outer box label and chart sticks, though the devices do match what is labeled on the inner tray itself.
The recalled devices were distributed nationwide across 18 states including Arizona, California, Georgia, Kansas, Louisiana, Minnesota, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Oregon, South Carolina, Tennessee, Virginia, Washington, and Wisconsin. The source does not specify what an affected consumer should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution in the states of AZ, CA, GA, KS, LA, MN, MI, MO, MS, NC, NJ, NY, OR, SC, TN, VA, WA, and WI. Quantity: 31 devices Lot/code info: Product #71420186 - Lot #21DM14954S, exp. October 2030, UDI #03596010206350. Product #71420166 - Lot #21FM13870A, exp. October 2030, UDI #03596010206268.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.