Recall Z-0596-2018 ยท HWA Impactor
Zimmer Biomet, Inc.
Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.
| Date | Aug 28, 2017 |
| Status | Terminated |
| Reason | Potential for the Persona Partial Knee Impactor Pad to fracture. |
| Root cause | Under Investigation by firm |
| Action | Consignees were notified of the recall via letter on about 08/28/2017. Instructions for distributors, sales representatives, and distributor operations leaders include to ensure affected team members are aware of the recall, review the list of hospitals included and note any not included that should be notified, and complete and return the Acknowledgement Form. Instructions for risk managers and surgeons include to ensure affected personnel are aware of the recall, ensure that the provided updated surgical technique is used, and complete and return the Certificate of Acknowledgement. Fur |
| Quantity | 1,275 units total |
| Distribution | US Nationwide Distribution in the states of 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, Switzerland, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.