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Class I Medical Device Recall: Ethicon Endo-Surgery, Inc. Proximate PPH Hemorrhoidal Circular Stapler and Accessories 33mm, Proximate HCS Hemorrhoidal Circular Stapler and Accessories 33mm and the Transtar Circular Stapler Procedure Set

Wed, 10/24/2012 - 12:00am
U.S. Food & Drug Administration

Recall Class: Class I

Date Recall Initiated: August 3, 2012

Product(s):

  • Ethicon PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code: PPH01)
  • Ethicon PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code: PPH03)
  • Ethicon TRANSTAR Circular Stapler Procedure Set (Product Code: STR10)

Lot numbers: All lots manufactured lots between April 16, 2011 to July 24, 2012.

Manufacturing and Distribution Dates: The affected products were manufactured from April 16, 2011 to July 24, 2012 and distributed from April 18, 2011 to July 23, 2012.

Use:
The PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories (Product Code: PPH01) are used in the surgical treatment of prolapse and hemorrhoids (PPH). This device also uses the Stapled Transanal Rectal Resection (STARR) surgical treatment of anorectal wall defects and obstructed defecation syndrome, with a single-fire staple. The device is also used in other applications where circular or semicircular stapling of anorectal tissue is needed. These devices are not currently marketed domestically.

The Proximate PPH Hemorrhoidal Circular Stapler and Accessories (Product Code: PPH03) are used in the surgical treatment of prolapse and hemorrhoids (PPH).

The TRANSTAR Circular Stapler and Accessories are used for the Stapled Transanal Rectal Resection (STARR) surgical treatment of anorectal wall defects and obstructed defecation syndrome. This is a multi-fire, single patient use device with a curved head that cuts and staples.

The major difference between the STARR and the PPH procedure is that STARR is a full thickness resection of the rectum which requires multiple staple firings, while PPH incorporates only the mucosa and submucosa and requires a singe stapled firing.

Recalling Firm:
Ethicon Endo-Surgery Inc.
4545 Creek Road
Cincinnati, Ohio 45242-2803

Reason for Recall: Users have difficulty firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation.

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. Failure to complete the firing stroke can also result in poor staple formation, dehiscence of the rectal wall staple line and bleeding.

This product may cause serious adverse health consequences, including death.

Public Contact: Customers with the device should contact Customer Support Center at 1-800-873-3636 or via email at customersupport@eesus.jnj.com for more information.

FDA District: Cincinnati District Office

FDA Comments:
Customers who have purchased the affected devices will be notified by letter through overnight delivery from Federal Express or UPS. All customers should respond to the included Business Reply Form indicating whether they have the affected devices, quantity of affected devices and if they have or will return the product(s).

Ethicon Endo-Surgery initiated this voluntary global recall for all lots manufactured from April 16, 2011 to July 24, 2012 of the PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH03) and Transtar Circular Stapler Procedure Set (STR10) due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
 

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