Faulty Device Has Higher Than Anticipated Rate Of Fracturing
On December 20, 2016, Zimmer Biomet issued a lot specific voluntary recall of its Comprehensive Reverse Shoulder Tray. Zimmer reported that devices manufactured between August 2008 and September 2011 have a “higher than anticipated rate of fracturing.” The notice stated design enhancements were made to devices manufactured after September 2011 that addressed device strength. The faulty shoulder trays were distributed between October 2008 and September 2015 and involved model number 115340. Lot numbers may be viewed here. On February 16, 2017, the Food and Drug Administration (FDA) announced that it had classified this as a Class I recall, the most serious recall category.
The shoulder replacement device is surgically implanted to restore movement in patients with rotator cuff injuries who have developed arthropathy, severe shoulder arthritis and have had previously failed shoulder replacement. Fractures of the device may require potentially dangerous revision surgeries that could result in loss of use, infection or even death. This shoulder replacement device was allowed on the market under the FDA’s 510(K) program which doesn’t require human clinical trials if the device is “substantially equivalent” to another already approved device.
If you have or had a Zimmer Biomet Comprehensive Reverse Shoulder Tray that has been recalled, or have had or plan to have revision surgery, please contact Martin & Jones for a free and confidential evaluation of your potential claim against the manufacturer. Our attorneys have represented clients in cases against some of the largest corporations in America. Call attorneys Forest Horne or Carrie Guest toll-free at 1.800.662.1234 or reach us by email by completing the contact us form.