Recall Z-1042-2015 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer, Inc.
Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
| Date | Feb 3, 2015 (initiated Nov 25, 2014) |
| Status | Terminated |
| Reason | Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; Revision surgery to remove the fractured tip |
| Root cause | Process control |
| Action | On 11/25/2014, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected distributors, hospital Risk Managers and Surgeons with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers, Surgeons, and distributors with affected inventory were also notified via courier. 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. For questions, call the customer call c |
| Quantity | 1,091 |
| Distribution | Worldwide distribution: US nationwide, including Puerto Rico, South Korea, Singapore, Dominican Republic, Canada, Japan, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113369 | ZIMMER PERSONA KNEE SYSTEM Zimmer, Inc., Mar 27, 2012 |