Stryker Gets 483 for Failure to Investigate Complaints

Stryker Instruments has received a Form 483 after failing to investigate complaints about autopsy saws because of the risk of infection. In one instance, a saw started smoking and a spring and side plate came off during use, but the device was not returned to the Kalamazoo, Mich., company for service due to the potential hazard associated with bioburden, the form says. According to Stryker documentation, the saws cannot be decontaminated. Stryker does not comment on FDA matters, the company said.
The GMP Letter