Z-1418-2022 Class II Terminated

Recalled by Smith & Nephew, Inc. — Memphis, TN

Recall Details

Product Type
Devices
Report Date
July 27, 2022
Initiation Date
June 27, 2022
Termination Date
March 25, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
31 devices

Product 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.

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 Pattern

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.

Code Information

Product #71420186 - Lot #21DM14954S, exp. October 2030, UDI #03596010206350. Product #71420166 - Lot #21FM13870A, exp. October 2030, UDI #03596010206268.