Washington, DC: The Food and Drug Administration (FDA) notified healthcare professionals of a Class 1 recall for Stryker Orthopaedics ShapeMatch Cutting Guide, due to a software defect that results in wider cutting ranges. The recall is prompted by 44 reports (41 malfunctions and 3 temporary medically reversible injuries) of incidents related to the ShapeMatch Cutting Guides received by the FDA to date.
According to a statement issued by the FDA, the parameters of the manufactured cutting guides may not meet the surgeon' pre-operative planning parameters entered via the web application. Additionally, Stryker Orthopaedics determined that another software defect resulted in the displayed parameters (e.g. depth of resection, angle of cut) not matching the cutting guides produced. This may result in serious adverse health consequences including joint instability, fracture, need for revision surgery and chronic pain and limitations of mobility.
The ShapeMatch Cutting Guides are single-use, disposable, cutting guides. They are intended to be used as surgical instrumentation to assist in the positioning of total knee replacement (arthroplasty) components intraoperatively and in guiding the marking of bone before cutting.
In November 2012, Stryker Orthopaedics e-mailed field locations, registered surgeons and imaging centers of the problem and to immediately stop prescribing, planning or performing operative or imaging procedures with the ShapeMatch Cutting Guides until further notice.
In January 2013, a Product Notification was issued to all branches, agencies, surgeons and risk managers at affected hospitals informing them of the problem and risk mitigation factors. On April 10, 2013, Stryker issued an Urgent Medical Device Recall.