Mich. Stryker to Recall Hip Surgery Product after Warning from Feds
Medical device maker Stryker Corp. announced earlier this week that it will voluntarily recall certain hip surgery products, a week after it received a warning from regulators.
The company is recalling Trident PSL and Hemispherical Acetabular Cups that were made in its Cork, Ireland plant. Stryker, whose orthopedics division is based in Mahwah, N.J., said there are no safety issues for patients who received these products, based on expert opinion.
Numerous published independent reports validate the long-term clinical performance of these products, the company said in a statement.
Last week, the Food and Drug Administration ordered Kalamazoo-based Stryker to fix a host of long-standing problems in its manufacturing of hip replacement parts that have triggered multiple patient complaints and forced some to have follow-up surgeries.
The FDA told Stryker in a letter that it was aware that the company has received patient complaints since January 2005 about a range of problems, including improper fitting of hip implants that caused bone fractures.
Products made at the company’s Mahwah plant are not part of the recall. That facility also includes administrative and research and development offices for the orthopedics division.
“While Stryker does not normally comment on discussions with the FDA, the company believes it is obligated to provide additional information to health care professionals, providers and patients in light of several media reports that draw erroneous conclusions surrounding the Warning Letter,” the company said in a statement.
The company expects some short-term supply disruption as a result of the recall. It said that in some cases, products did not meet “internal acceptance criteria,” even though they met U.S. and international performance standards.
However, Stryker said it does not expect the voluntary recall to affect its guidance for its 2008 results.
It plans to provide details on its sales and earnings outlook when it reports fourth-quarter 2007 operating results on Wednesday.
Stryker shares fell $1.11, or 1.7 percent, to $64.75 in regular trading Tuesday, then rebounded by the same amount in after-hours trading.