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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1418-2022 |
| Event ID | 90547 |
| 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 Type | Devices |
| 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 |
| Recall 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. |
| Device Classification | 20220727 |
| Device Code Info | Product #71420186 - Lot #21DM14954S, exp. October 2030, UDI #03596010206350. Product #71420166 - Lot #21FM13870A, exp. October 2030, UDI #03596010206268. |
| Center Classification Date | 20220720 |
| Recall Initiation Date | 20220627 |
| Recalling Firm | Smith & Nephew, Inc. |
| Initial Notification | Letter |
| Similar To |