CHICAGO (Reuters) - Stryker Corp said on Tuesday it is recalling some artificial hip products manufactured at its Cork, Ireland, facility because the devices did not meet company standards for sterility.
The orthopedic device maker said it is voluntarily recalling the Trident PSL hip implant components and Hemispherical Acetabular Cups after finding they failed to meet internal specifications, but said it does not believe the products pose a safety risk to patients.
Stryker said tests it conducted after the U.S. Food and Drug Administration in November warned it about malfunctioning hip parts found the level of manufacturing “residuals” sometimes exceeded company standards.
The products, however, meet U.S. and international standards for sterility and compatibility in the human body, the company said.
Stryker said its sees no material impact on its 2008 outlook, but expects some short-term supply disruption from the recall. The company has validated the manufacturing process for the acetabular cups in Cork and resumed shipment of those products while increasing production at both its Cork and Mahwah, New Jersey, facilities.
The FDA in its November warning letter to Stryker cited quality problems in manufacturing processes at the Mahwah facility and said it had received complaints that certain Trident hip components failed to function, causing some patients to need additional surgery.
The FDA sent Stryker a separate warning letter last March, citing the company’s failure to remedy quality problems at the Cork plant.
Stryker shares fell 77 cents, or 1.17 percent, to $65.09 in morning trading on the New York Stock Exchange.
Reporting by Susan Kelly, editing by Dave Zimmerman