WASHINGTON, Jan 15 (Reuters) - U.S. regulators have warned medical device maker Stryker Corp (SYK.N) about manufacturing problems linked to some malfunctioning implant parts.
At times, the malfunctions were serious enough to require additional surgery.
A copy of a warning letter send to Stryker was posted on the U.S. Food and Drug Administration Web site on Tuesday. It said infractions at the company’s Mahwah, New Jersey, plant included failure to fix quality problems, including those related to its Trident hip-replacement systems. The 11-page letter was dated Nov. 28, 2007.
The FDA said there were customer complaints about squeaky ceramic hip joints, among other problems.
The agency sends dozens of warning letters each year. Most are resolved without further action. In rare cases, the letters can result in product seizures or hold up approval of new products. (Reporting by Kim Dixon; editing by John Wallace)