Ethicon Endo-Surgery Inc: 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.

Recall number

Z-0980-2007

Recalling firm

Ethicon Endo-Surgery Inc

Product

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.

Status

Terminated

Initiated

2007-04-02

Posted

2007-06-28

Terminated

2009-12-09

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.

Root cause

Other

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.

Quantity

23,966 units

Distribution

Worldwide, including USA and Canada.

Lot, serial or model codes

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.

510(k) numbers

["K051301"]

PMA numbers

not on file

Product code

GDW

Firm FEI

1527736

Firm city

Cincinnati

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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