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

Mon, 10/29/2012 - 8:29am
Mass Device

Johnson & Johnson subsidiary Ethicon Endo-Surgery's global surgical stapler recall gets Class I status from the FDA over concerns that difficulties with the devices' firing mechanisms may injure patients.

MassDevice On Call

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.

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