Events

Recall of Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    37872
  • Event Risk Class
    Class 2
  • Event Number
    Z-0980-2007
  • Event Initiated Date
    2007-04-02
  • Event Date Posted
    2007-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52012
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    stapler - Product Code GDW
  • Reason
    The adhesive used to bond the casing of the device may have migrated to the staple driver. while the device still fires, it may result in audible and tactile feedback at the midpoint of the firing cycle which may be interpreted by some surgeons as a completed firing cycle, which may cause the surgeon to prematurely stop firing the device and result in incomplete staple formation or cut line.
  • Action
    The recalling firm sent a recall letter dated 04/02/07 to foreign consignees and a second letter dated 04/03/07 to their United States consignees. The letter asks that the customers: 1) Examine their inventories for the presence of the affected product and remove it from inventory if found; 2) Complete the Business Reply Form and fax it to Stericycle their representative and 3) Return all affected product in order to received credit, along with the completed Business Reply Form in the box identified with a pre-printed UPS shipping label supplied by the recalling firm.

Device

Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03
  • Model / Serial
    C4ER8H, C4ET81, C4ET82, C4ET91, C4ET83, C4ET92, C4EU22, C4EU23, C4EU2U, C4EU4M, C4EU4N, C4EU2V, C4EV7K, C4EV7L, C4EV7J, C4EV9D, C4EV9E, C4EW2A, C4EW2W, C4EV9C, C4EW58, C4EW59, C4EW57, C4EW6T, C4EW6U, C4EW8T, C4EW8R, C4EX9V, C4EX9T, C4EY41, C4EY42, C4EY43, C4EX9U, C4EY82, C4EY81, C4EY83, C4EZ1D, C4EF01P, C4F01R, C4F01T, C4F03D, C4F03C, C4F05G, C4F114, C4F116, C4F115, C4F12K, C4F12L, C4F12M, C4F143, C4F142, C4F303, C4F14C, C4F31T, C4F33F, C4F34W, C4F34X, C4F35N, C4F380, C4F406, C4F41E, C4F422, C4F407, C4F42L, C4F433, C4F432, C4F44G, C4F44F, C4F456, C4F455, C4F56C, C4F56D, C4F583, C4F58J, C4F58H, C4F60N, C4F60M, C4F62Y, C4F58T, C4F62Z, C4F630, C4F694, C4F695, C4F72Y, C4F715, C4F850, C4F852, C4F84Z, C4F851, C4F86Z, C4F86W, C4F86X, C4F853, C4F854, C4FD16, C4FD17, C4FD5P, C4FD5R, C4FD9X, C4FD9Y, C4FE58, C4FE59, C4FE7C, C4FE7D, C4F851, C4FF43, C4FF4Y, C4FF4Z, C4FF8N, C4FF8P, C4FG20, C4FG6K, C4FH11, C4FH12, C4FH2P, C4FH2R, C4FH7F, C4FH8X, C4FH8Y, C4FJ00, C4FH7G, C4FJ92, C4FJ8K, C4FK05, C4FL05, C4FK9U, C4FL00, C4FM02, C4FM01, C4FM18, C4FN0L, C4FN0G, C4FN80, C4FN78, C4FN5X, C4FN8P, C4FP0N, C4FP0P, C4FP2W, C4FP2X, C4FP5X, C4FR1V, C4FP9V, C4FR3C, C4FM2R, C4FR79, C4FT0G, C4FR7A, C4FT0F, C4FM2T, C4FT1K, C4FT23, C4FT24, C4FT25, C4FT37, C4FT4D,   C4FT38, C4FT5D, C4FU70, C4FV36, C4FV2L, C4FU71, C4FV6Y, C4FV7T, C4FV7V, C4FW0N, C4FW0M, C4FW13, C4FW35, C4FW3P, C4FW3M, C4FW34, C4FW3N, C4FW6P, C4FW6T, C4FX0N, C4FX22, C4FY0A, C4FY0D, C4FY0C, C4FY6F, C4FY6M, C4FY6G, C4FZ1L, C4FZ1K, C4FZ2G, C4FZ3D, C4FZ3E, C4FZ4C, C4FZ1L, C4G001, C4FZ9Z, C4G000, C4G04E, C4G04G, C4G04F, C4G06T, C4G06R, C4G086, C4G108, C4G085, C4G107, C4G12E, C4G148, C4G12F, C4G20Y, C4G20X, C4G23W, D4G34J, D4G34K, D4G34L, D4G37V, D4G37W, D4G460, D4G45Z, D4G483, D4G492, D4G494, D4G484, D4G482, D4G493, D4G49T, D4G63A, D4G63D, D4G63C, D4G851, D4G864, D4G86U, D4G87Y, D4G88Z, D4G890, D4G986, D4G987, D4G985, D4GA22, D4GA23, D4GA21, D4GD5T, D4GD5R, D4GD5U, D4GE16, D4GE17, D4GE6L, D4GE6K, D4GG09, D4GG0A, D4GG0C, D4GG6A, D4GG6C, D4GG8H, D4GG8J, D4GH0Y, D4GH1J, D4GJ0F, D4GH8F, D4GH8D, D4GJ3H, D4GJ3G, D4GJ49, D4GJ5W, D4GJ48, D4GJ7K, D4GJ7P, D4GJ7R, D4GK4D.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA and Canada.
  • Product Description
    Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03. Each set contains: 1 hemorrhoidal circular stapler, 1 suture threader, 1 circular anal dilator, and 1 purse string suture anoscope.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Manufacturer Address
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA