Recall: Ethicon Endo-Surgery pulls surgical staplers over performance issues
August 13th, 2012 // 1:53 pm @ jmpickett
Johnson & Johnson subsidiary Ethicon Endo-Surgery initiated a global recall of certain lots of its Proximate surgical staplers and accessories over concerns about firing issues.
Ethicon Endo-Surgery Proximate Surgical Stapler
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery pulled more than 500 lots of its Proximate surgical staplers over performance issues that may cause the devices to misfire.
The medical device company issued a global recall of certain lots of its Proximate PPH and HCS hemorrhoidal circular staplers and accessories “due to difficulty firing the device which may result in incomplete firing stroke, that may result in an incomplete staple formation,” according to the recall report.
“The voluntary recall is being conducted with the full knowledge of the U.S. Food and Drug Administration,” according to the report. “We are working to implement actions to resume production.”
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Ethicon asked that healthcare providers return all affected products by November 5 in order to receive a credit. Ethicon did not respond to requests for comment.
The recall notice hasn’t yet been filed on the FDA website, but the federal watchdog agency’s MAUDE adverse event reporting system contains dozens of incidents related to the Proximate stapler. There are 8 incidents reported for June alone, though not all appear related to the firing issue noted in the recall.
A report filed May 21 stated that “during a procedure for prolapse and hemorrhoids device was very hard to fire.”
