Class 1 FDA Recall of Stryker Orthopaedics ShapeMatch Cutting Guide
On April 10, 2013, the FDA issued a Class 1 recall – the most urgent recall the FDA will issue – of the Stryker Orthopaedics ShapeMatch Cutting Guide. The recall occurred because a computer software defect was causing wider cutting ranges.
The Stryker ShapeMatch Cutting Guide is a system used during the pre-operation stage of a total knee replacement (arthroplasty). The patient undergoes an MRI that creates a 3D image of the knee. The Stryker ShapeMatch Cutting Guide, used with the Triathlon Knee System, then would assist the surgeon in choosing the correct size, position and alignment of the “new knee.” The manufacturer claimed that using this technique would provide a better outcome.