Orthopedic-device maker Stryker, Kalamazoo, Mich., has resolved concerns over quality-control problems at its Mahwah, N.J., hip implant manufacturing facility, according to a news release.
Stryker resolves FDA concerns at N.J. plant
The problems were originally cited in a warning letter that Food and Drug Administration officials sent to the devicemaker in November 2007 following an inspection of the plant. The warning prompted Stryker to recall its Trident hip replacement cups, which had been the source of multiple improper-fit complaints from patients.
FDA officials reinspected the plant in 2009, after which Stryker took additional corrective action. The devicemaker was recently informed that the actions adequately addressed the agency's concerns, according to the news release.
Orthopedic-device maker Stryker, Kalamazoo, Mich., has resolved concerns over quality-control problems at its Mahwah, N.J., hip implant manufacturing facility, according to a news release.
The problems were originally cited in a warning letter that Food and Drug Administration officials sent to the devicemaker in November 2007 following an inspection of the plant. The warning prompted Stryker to recall its Trident hip replacement cups, which had been the source of multiple improper-fit complaints from patients.
FDA officials reinspected the plant in 2009, after which Stryker took additional corrective action. The devicemaker was recently informed that the actions adequately addressed the agency's concerns, according to the news release.
What do you think? Post a comment on this article and share your opinion with other readers. Submit your comments to Modern Healthcare Online at [email protected]. Please be sure to include your hometown and state, along with your organization and title.
Letter
to the
Editor
Send us a letter
Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.
Sponsored Content