Medical device maker Stryker Corp. said Wednesday it recalled 322 custom-made cranial implant kits because of possible sterility issues, which the Food and Drug Administration advised could be lethal.
Stryker recalled all kits distributed between Nov. 5, 2007, and Oct. 23, 2008 because it can't be sure the kits were properly sterilized. Physicians received a recall letter Oct. 24, and on Thursday the FDA deemed the recall a Class 1, meaning there is a reasonable probability that use of the product will cause serious injury or death.
Physicians who used the implant kits were advised to follow up with patients for at least six months after surgery to check for infections. The letter also told patients how to identify and return any remaining implant kits.
The cranial implant kits are used to correct defects in the jaw and face, or cranium and face.
Stryker shares gained 16 cents to $40.05 in abbreviated trading Wednesday.
Stryker recalled all kits distributed between Nov. 5, 2007, and Oct. 23, 2008 because it can't be sure the kits were properly sterilized. Physicians received a recall letter Oct. 24, and on Thursday the FDA deemed the recall a Class 1, meaning there is a reasonable probability that use of the product will cause serious injury or death.
Physicians who used the implant kits were advised to follow up with patients for at least six months after surgery to check for infections. The letter also told patients how to identify and return any remaining implant kits.
The cranial implant kits are used to correct defects in the jaw and face, or cranium and face.
Stryker shares gained 16 cents to $40.05 in abbreviated trading Wednesday.
By MARLEY SEAMAN
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