J&J surgical stapler recall gets Class I status from the FDA | MassDevice.com On Call

October 29, 2012 By MassDevice staff Leave a Comment

MASSDEVICE ON CALL — Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery’s global surgical stapler recall got Class I status from the FDA over concerns that issues with the devices’ firing mechanisms may injure patients.

MassDevice.com in August reported on the recall, which involves certain lots of Ethicon’s Proximate PPH and HCS hemorrhoidal circular staplers and accessories, when the company notified authorities in Hong Kong of the recall.

J&J launched the recall over issues firing the device, which could result in incomplete staple formation, according to the Hong Kong letter.

"Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal," according to the FDA notice. "Failure to complete the firing stroke can also result in poor staple formation, dehiscence of the rectal wall staple line and bleeding."

The recall affects more than 157,000 surgical stapling systems distributed worldwide, the Wall Street Journal reported.

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