Recall Z-0123-2015 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer, Inc.
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate.
| Date | Oct 23, 2014 (initiated Oct 7, 2014) |
| Status | Terminated |
| Reason | Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip. |
| Root cause | Process control |
| Action | Zimmer sent an " URGENT MEDICAL DEVICE RECALL - LOT SPECIFIC " notifications dated September 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST. |
| Quantity | 618 units |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of Korea, Singapore, Canada and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113369 | ZIMMER PERSONA KNEE SYSTEM Zimmer, Inc., Mar 27, 2012 |