Stryker Corp recalling some...

CHICAGO (Reuters) Jan 22 - Stryker Corp said on Tuesday it is recalling some artificial hip products made at its Cork, Ireland, facility because the devices did not meet company manufacturing standards.

The orthopedic device maker said it is voluntarily recalling the Trident PSL hip implant components and Hemispherical Acetabular Cups because tests revealed the level of manufacturing "residuals" sometimes exceeded company standards.

It said it does not believe the products pose a safety risk to patients, and noted the devices meet U.S. and international standards for sterility and compatibility in the human body.

Stryker said it conducted the tests after the U.S. Food and Drug Administration in November warned the company about manufacturing problems linked to malfunctioning hip parts.

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 some 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.