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Smith & Nephew, Inc. Recall 90547

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

Smith & Nephew, Inc. Recall 90547 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1418-2022
Event ID90547
Event Description(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
Product TypeDevices
DistributionUS 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.
Quantity31 devices
Recall ReasonThe 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.
Device Classification20220727
Device Code InfoProduct #71420186 - Lot #21DM14954S, exp. October 2030, UDI #03596010206350. Product #71420166 - Lot #21FM13870A, exp. October 2030, UDI #03596010206268.
Center Classification Date20220720
Recall Initiation Date20220627
Recalling FirmSmith & Nephew, Inc.
Initial Notification Letter
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