FDA Announcement March 12, 2015 – Medical Implant Product Recall: Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello / Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer / Metal / Polymer
Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial knee implant device following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution.
Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on 2/16/2015 via mail. Customers are asked to review the notification and ensure affected personnel are aware of the contents. All affected product are to be located and quarantined immediately.