On March 12, 2015, the US Food and Drug Administration (FDA) issued a Class 2 Recall for all lots and sizes of Zimmer's Persona® Trabecular MetalTM Tibial Plate knee implant. This is one of the three major components used in a total knee replacement
- More than 11,000 units were recalled worldwide.
- This knee replacement was approved for use in the US on 11/29/2012
- According to the FDA, Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on 2/16/2015 via mail.
- The reason Zimmer, the manufacturer, gave the FDA for the recall is an "increase in complaints of loosening and radiolucent lines. Radiolucent lines are only seen on x-rays and may indicate loosening. Symptoms of loosening can include an increase in knee pain, loss of motion, difficulty ambulating, giving way, popping and instability. Another surgery, called a revision is required to replace the loose tibial component.
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Friedman Law Offices, P.C., L.L.O. is here to help. To schedule a free consultation with our Lincoln, Nebraska medical Device attorneys, contact us online in Lincoln, Nebraska, or by calling 866-458-5468 or toll free 888-419-6876.