Recall Z-0833-2019 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Signature Orthopedics Pty Limited
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
| Date | Dec 10, 2018 |
| Status | Terminated |
| Reason | Product mix up |
| Root cause | Mixed-up of materials/components |
| Action | On 12/10/2018 the firm sent letters to their customer informing them of the recall and asked the customers to Immediately examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall by forwarding this letter. Please complete the attached Customer Acknowledgement Form and fax or email it to us so that we may arrange for your stock to be recovered and replacement stock, or a credit note, issued. Please complete the Customer Acknowledgement Form even if yo |
| Quantity | 10 |
| Distribution | US Nationwide Distribution in the states of FL, NY, and TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170613 | Genius Total Knee System Signature Orthopaedics Pty, Ltd., Jul 17, 2017 |