FDA Enforcement
Class II
Terminated
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
Recall: Z-1418-2022
·
Reported July 27, 2022
Enforcement
- Recall Number
- Z-1418-2022
- Event ID
- 90547
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Smith & Nephew, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 27, 2022
- Initiation Date
- June 27, 2022
- Classification Date
- July 20, 2022
- Termination Date
- March 25, 2026
- Address
- 1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States
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
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 Info
Product #71420186 - Lot #21DM14954S, exp. October 2030, UDI #03596010206350. Product #71420166 - Lot #21FM13870A, exp. October 2030, UDI #03596010206268.
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