Devicemaker Stryker Corp., Kalamazoo, Mich., initiated a voluntary recall of Trident replacement hip cups manufactured at its facility in Ireland and at the same time downplayed the findings of a warning letter the company received from the Food and Drug Administration regarding quality control at its plant in Mahwah, N.J.
Based on FDA observations made during an inspection of the Ireland site, Stryker conducted an internal investigation and found that “manufacturing residuals in some cases exceeded the company’s internal acceptance criteria,” the company said in a written statement, which adds that “there are no safety issues for patients who received these products.”
Meanwhile, an FDA letter sent to Stryker in November and published on the agency’s Web site Jan. 15 cites quality-control problems involving Trident cups made at the company's New Jersey facility. “The company does not believe there is any clinical evidence to indicate that the products mentioned in the warning letter present a safety issue to patients,” Stryker said, arguing that media reports had reached “erroneous conclusions” from the letter.
The company predicted some “short-term supply disruption” as a result of the recall and does not expect any material impact on its financial results. -- by Gregg Blesch
