Recall Z-0628-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
| Date | Aug 25, 2017 |
| Status | Terminated |
| Reason | The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension. |
| Root cause | Process change control |
| Action | Consignees were notified via mail on approximately 08/25/2017. Instructions to distributors, sales representatives, and distributor operations managers include to ensure affected team members are aware of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide any additional hospitals and/or surgeons that received direct shipments. Instructions to risk managers and surgeons include to ensure affected personnel are informed of the recall, quarantine all affected product, return any aff |
| Quantity | 11 devices |
| Distribution | US Nationwide Distribution to IN, MO, NY, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K833921 | AGC TOTAL KNEE PROSTHESIS Biomet, Inc., Jan 31, 1984 |