A Medical Device Daily

Stryker (Kalamazoo, Michigan) has issued a statement saying that two of its products cited in an FDA warning letter recently posted by the agency offer no risk to patient safety, but that it is recalling the products anyway because they “in some cases exceeded” its own internal criteria.

The company said that because of this “deviation from internal specifications,” it is voluntarily recalling its Trident PSL and Hemispherical Acetabular Cups manufactured in its Cork, Ireland, facility.

There is “no clinical evidence to indicate that the products mentioned in the letter represent a risk to patient safety,” it said.

The finding of deviations from specification was the result of “a comprehensive review and investigation” of its internal processes, it said. And while it noted the exceeding of its internal standards, it said that the review indicated that all Trident Acetabular products manufactured in Cork, Ireland, have met all U.S. and international performance standards for sterility and biocompatibility. It also cited “independent clinical evidence” that favorable performance of these devices “compares ... with other high-performing acetabular devices.”

Stryker said it does not usually comment on its discussions with the FDA but that it feels obligated “to provide additional information to healthcare professionals, providers and patients in light of several media reports that draw erroneous conclusions surrounding the Warning Letter.”

Its Trident Acetabular Cups manufactured in its Mahwah, New Jersey, facility are not part of the recall, it said.

Stryker said it is cooperating with the FDA to address the agency’s observations concerning its “internal process specifications.” While it acknowledged some short-term disruptions in product supply, it said that the “manufacturing process for these cups in Cork has been validated, product shipments have resumed” and it has ramped up production at both the Mahwah and Cork facilities.

The company said it did not foresee any “material” financial impact on its guidance for 2008 as a result of the recall.

It promised additional details concerning its ’08 outlook during its 4Q07 statement to be released Jan. 23.