Recall Z-1418-2022 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
| Date | Jun 27, 2022 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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 th |
| Quantity | 31 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951987 | GENESIS II TOTAL KNEE SYSTEM Smith & Nephew Richards, Inc., Aug 22, 1995 |