Knee Replacement Device Complaints. Indiana-based medical device maker Zimmer, Inc. has announced a voluntary recall of 11,658 Persona Trabecular Metal Tibial knee replacement devices following an increase in complaints of radiolucent lines and loosening of the device.
The recall covers the Persona Trabecular Metal Tibial Plate/Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, all lots land sizes, left and right. Research has shown that radiolucent lines, which show the gap between the cement and the device component, can be associated with early failure of the device. Recipients may need revision surgery to replace the defective component.
Class II Recall
This is a Class II recall, the Food and Drug Administration (FDA) category for situations in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The recalled devices were distributed in the U.S. in Alaska, Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin, and in Canada, Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, Luxembourg, Netherlands, South Africa, Sweden, Switzerland, and United Arab Emirates.
According to the recall announcement, all sizes and lots of the affected devices are being removed from distribution. Urgent Medical Device Recall notices were mailed to distributors, hospitals, and surgeons last month. The company asked that affected products be quarantined immediately and returned to the company. Customers may contact Zimmer at 1-877-946-2761, 8:00 a.m. and 5:00 p.m. EST, with any questions about the recall.
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