Stryker Corporation has issued a voluntary recall of yet another product used in orthopedic surgeries. In July of 2012, Stryker recalled its Rejuvenate and ABG II modular-neck hip stems used in conjunction with hip replacement surgeries. More recently, Stryker Corporation has acknowledged defects with its ShapeMatch Cutting Guides used to assist in the positioning of total knee replacement components. On April 10, 2013, Stryker issued an urgent medical device recall of the ShapeMatch Cutting Guides. This was classified as a Class I recall by the U.S. Food and Drug Administration, which means that there is a reasonable probability the product can cause serious adverse health consequences or death.
The ShapeMatch Cutting Guides were used with the Triathlon Knee System. The recalled products are single use, disposable cutting guides used as surgical instruments to assist the surgeon in positioning the total knee replacement components and guiding the marking of bone before the surgeon begins cutting. The product was recalled due to a software defect that resulted in wider cutting ranges. Additionally, Stryker determined that a separate software defect resulted in displayed parameters for the depth of resection or the angle of cut not matching the cutting guides produced. It was determined that these defects could result in injuries, including joint instability, fracture, chronic pain, limited mobility of the knee and the need for revision surgery.
Patients who have had knee replacement surgery during which the ShapeMatch Cutting Guides were used and who feel their knee is not functioning properly should contact their orthopedic surgeon. If it is determined that the patient is experiencing joint instability, fracture, chronic pain, or limited mobility in the knee, any of which could necessitate revision surgery, he or she should contact the experienced defective medical device attorneys at Suthers & Harper on our toll free number, 1-800-320-2384, for a free consultation. Suthers & Harper is presently representing numerous individuals in pending lawsuits against the manufacturers of defective hip replacement and knee replacement products, and has the experience and resources necessary to hold the product manufacturers accountable for their defective products.