In April, Stryker Corporation initiated a Class I recall of ShapeMatch Cutting Guides, in cooperation with the U.S. Food and Drug Administration (FDA).
The device is intended to be used as single-use, disposable cutting guides for use during surgical instrumentation to assist in the positioning of total knee replacement components as well as guiding in the marking of the bone before cutting. They are used in conjunction with the Triathlon Knee System.
Stryker Recall Details
A Class I recall is described by the FDA as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
All Product Codes & Lot Numbers were included in the recall.
The agency has received a total of 44 patient reports (41 malfunctions and 3 temporary medically reversible injuries)
The recall was issued because the devices may not have been manufactured in accordance with surgeon preoperative planning manufacturers or they may have been manufactured outside of the planning ranges that are required in the 510(k) clearance.
This voluntary recall does not affect the Triathlon Knee System or the Triathlon standard instrumentation.
Patients that have undergone knee replacement surgery in which the ShapeMatch Cutting Guides were used and/or who are experiencing adverse symptoms are urged to contact their surgeon immediately. However, if the patient is symptom-free they should continue regular follow-ups with their surgeon as scheduled.
It is important for patients to understand their rights when dealing with defective medical products. If you or a family member has been injured as a result of a defective device, you should consult an attorney as soon as possible. The first step toward staying healthy is knowledge and remembering that timing is of the essence. If something doesn’t feel right don’t wait to contact your surgeon, the sooner the better.