Device recall

Z-0057-2013: Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE…

FDA device recall · Class I · Ethicon Endo-Surgery Inc

Key facts

Recall number (Z-number) Z-0057-2013
Recall event 62879
Product Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculo mucosal…
Product code GDW
Recalling firm Ethicon Endo-Surgery Inc
Recall class Class I
Status Terminated
Termination date Jul 12, 2013
510(k) numbers K030411, K030925, K051301, K991030
FEI number 1527736

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)