Stryker Recalls Hip Replacements Following FDA Warning Letter
January 23rd, 2008 joshua
Stryker Corp. will participate in a voluntary recall of hip surgery parts after the Food and Drug Administration told the company it knew of complaints it received since 2005.
The Associated Press reports Stryker is recalling Trident PSL and Hemispherical Acetabular Cups that were made in its Cork, Ireland plant. Stryker said there are no safety issues for patients who received these products.
The FDA told Stryker to fix problems with the manufacture of these products. Apparently poor fittings were causing additional pain for recipients and in some cases, bone fractures. The voluntary recall does not include parts made in Stryker’s Mahwah, N.J., facility.
“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.
Stryker Corp. will participate in a voluntary recall of hip surgery parts after the Food and Drug Administration told the company it knew of complaints it received since 2005.
The Associated Press reports Stryker is recalling Trident PSL and Hemispherical Acetabular Cups that were made in its Cork, Ireland plant. Stryker said there are no safety issues for patients who received these products.
The FDA told Stryker to fix problems with the manufacture of these products. Apparently poor fittings were causing additional pain for recipients and in some cases, bone fractures. The voluntary recall does not include parts made in Stryker’s Mahwah, N.J., facility.
“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.
