Stryker Corp. (NYSE:SYK) said the Food & Drug Administration cleared an implant factory in Cork, Ireland, and a Michigan distribution facility of problems flagged in a pair of warning letters issued in 2007 and 2009.
According to a heavily redacted copy of the 2007 warning letter on the FDA’s website, an inspection of the Cork plant in 2006 turned up problems with the way the plant tracked “non-conforming” products, how changes to the manufacturing process were logged and with the procedure for repairing the non-conforming products. The facility makes several brands of Stryker implants, including Duracon and Scorpio knee replacement components; Trident, Accolade and Restoration hip replacement systems; and the Dall-Miles reconstruction & trauma cable system.
The company proposed fixes for the problems in late 2006, only some of which the FDA deemed adequate at the time, according to the letter.
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The 2009 letter involved problems with the distribution of Stryker’s custom cranial implant from a facility in Portage, Mich. The agency said Stryker failed to notify it of changes to the device and that it had begun marketing the device as sterile, when its original pre-market approval in 2005 indicated it was non-sterile.
Stryker said the resolution clears the last two extant FDA warning letters concerning its operation. Company officials declined to provide MassDevice with copies of the FDA missives clearing the warning letters. The warning letters were not yet posted on the FDA’s website; an FDA spokesman did not immediately respond to an email seeking confirmation.
Stryker stock prices closed at $55.72 May 19, down 0.34 percent.
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The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
