Wednesday, August 16, 2006

FDA Warns Surgical Pin and Wire Maker

Medical devices known as Kirschner wires and Steinmann pins made by a Teleflex Inc. plant failed specifications, according to an FDA letter to Teleflex.

The warning letter issued in July can be found on the FDA's Web site. It cited an inspection at the company's Research Triangle Park, N.C., facility. The letter said that, after finding out there were problems with the Kirschner wire and Steinmann pins, Teleflex did not re-evaluate and reinspect the lots that had been released for distribution to determine the extent and seriousness of the problem.

Teleflex was in the news back in October of 2005 when the then-FDA head Lester Crawford sold shares in the company. "Financial disclosure issues" may have played some role in his exit from the FDA, according to news reports.

Sources include Reuters, Bizjournal.