“The Food & Drug Administration (FDA) on March 12, 2015 announced a Class 2 Recall of about 11,658 Zimmer Persona knee implant Tibial components* parts because of radiolucent lines and premature loosening. Distributed from 2012 through January 2015 due to the recall, the Persona knee was marketed as “The Personalized Knee System” by Zimmer Inc. Since it launch, the Persona has been linked to numerous failures and complications from patients all of the United States.
Per to the FDA: “An increase in complaints of loosening and radiolucent lines” was noted in the Persona knee system and has been investigated for device failures.
This Class 2 Zimmer knee recall relates to the following component parts:
Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining orsacrificing surgical procedures.
As stated by the FDA:
Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial 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.”
*Tibial component (knee): Portion of a knee prosthesis that is used to replace the articulating surface of the tibia (shin bone) at the knee joint.
knee joint, medical devices are now recalled |
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