Zimmer, Inc., the Indiana-based medical device maker, has initiated a voluntary recall of 11,658 Persona Trabecular Metal Tibial knee replacement devices because of increased reports 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. Radiolucent lines, which are seen on x-rays, show the gap between the cement and the device component, and can be associated with early failure of the device and some recipients have needed revision surgery to replace the defective knee component.
The recalled devices were distributed worldwide: 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 internationally in Canada, Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, Luxembourg, Netherlands, South Africa, Sweden, Switzerland, and United Arab Emirates.
The Food and Drug Administration (FDA) has classified this as a Class II recall. In a Class II recall, “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,” according to the FDA.
Zimmer is removing all sizes and lots of the devices from distribution and send Urgent Medical Device Recall notices to distributors, hospitals, and surgeons last month. Customers should quarantine the affected products immediately and return them to the company. For questions about the recall, customers should contact Zimmer at 1-877-946-2761, from 8:00 a.m. to 5:00 p.m. EST.