(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
- Company
- Smith & Nephew Inc
- Recall Initiated
- June 27, 2022
- Recall Number
- Z-1418-2022
- Quantity
- 31 devices
- Firm Location
- Memphis, TN
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
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.
Lot / Code Info
Product #71420186 - Lot #21DM14954S, exp. October 2030, UDI #03596010206350. Product #71420166 - Lot #21FM13870A, exp. October 2030, UDI #03596010206268.
Root Cause
Process control
Action Taken
The recalling firm issued letters dated 6/27/2022 via email and overnight mail on 6/27/2022. The letter described the issue, product details, shipment dates, potential risk of use of the product, and said that the required actions could be found on the attached response form. The response form was flagged that all items are to be completed and the form is to be returned within 5 days of receipt. The required actions instructed the consignee to inspect their inventory and quarantine the affected product. If the consignee is a sales rep, district office, or a distributor, they must notify their customers of the field action and ensure the required actions are complete. If there is no product to return, they are to check the appropriate box to indicate no product is being returned. If there is product to return, they are to complete the form and list the product part number, batches, and quantities they are returning. By signing the form, they are confirming their organization is aware of the field action and it has been communicated throughout the organization.