Device 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.
Z-1418-2022
Product summary
- Event
- Event 90547
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31 devices
- Official record key
device-enforcement:Z-1418-2022
Official wording
Reason: 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.
Code information: Product #71420186 - Lot #21DM14954S, exp. October 2030, UDI #03596010206350. Product #71420166 - Lot #21FM13870A, exp. October 2030, UDI #03596010206268.
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.
Derived failure modes
-
Labeling or packaging
mispackaged