Recall Z-0349-2018 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Zimmer Biomet, Inc.
Persona Partial Knee System, Size 8, Finishing Guide
| Date | Jul 5, 2017 |
| Status | Terminated |
| Reason | Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion. |
| Root cause | Device Design |
| Action | Customers were notified via FedEx mail and email on approximately 07/05/2017. Instructions included to notify appropriate personnel, complete and return the Acknowledgement Form, return affected product, and provide contact information of additional hospitals or surgeons that used the affected product. |
| Quantity | 158 devices |
| Distribution | Distributed domestically to AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161592 | Persona Partial Knee System Biomet, Inc., Nov 3, 2016 |