FDA Classifies Stryker ShapeMatch Recall Class I

Stryker Corporation announced on April 10, 2013 that the FDA has classified the voluntary recall of the company’s ShapeMatch Cutting Guides as a Class I Recall.

A Class I Recall, according to the FDA, is 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.”

Stryker told surgeons to discontinue using and ordering the guides last November and recalled the device in January 2013. The company said the actions were due to the potential that ShapeMatch Cutting Guides may not have been manufactured in accordance with surgeon preoperative planning parameters or may have been manufactured outside of the planning ranges specified in the 510(k) clearance.

The problem was identified through standard post-market surveillance of product complaints. A Product Notification was issued to surgeons and hospital risk managers which described the known hazards and harms potentially associated with the use of the affected products, which could result in a knee not functioning properly.

The guides are intended to be used as patient specific surgical instrumentation to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. They are designed to be used exclusively with the company’s Triathlon knee replacement system. The device had secured the 510(k) approval in May 2011.

Patients who have had knee replacement surgery in which ShapeMatch Cutting Guides were used and who feel their knee may not be functioning properly should contact their surgeon. Patients may also contact Stryker at 1-888-STRYKER with questions regarding this Class I recall Monday – Friday, 8am-8pm Eastern time.

More Quality Issues

Stryker has been going through a spate of quality issues lately. Just last month the company received a warning letter from the FDA following an inspection at its Portage, Michigan facility. The warning was issued due to a quality systems-related issue at the facility as well as the marketing of unapproved medical devices, including the Neptune Waste Management system. In June 2012, Stryker started a Class 1 recall of its Neptune system due to the severe injuries caused by the device.

Stryker also issued a global recall of the Rejuvenate and the ABG II Modular hip stem in June 2012 due to some product defaults, which caused adverse local tissue reactions.

Company CEO, Kevin Lobo and the new head of orthopedics, David Floyd have inherited these problems. How they resolve them is being watched closely by surgeons and Wall Street.