Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03. Each set contains: 1 hemorrhoidal circular stapler
FDA device recall Z-0980-2007 · posted 2007-06-28 · Terminated
Recall details
- Recalling firm
- Ethicon Endo-Surgery Inc
- Reason for recall
- 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 taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GDW
- Quantity affected
- 23,966 units
- Distribution
- Worldwide, including USA and Canada.
- Date initiated
- 2007-04-02
- Date posted
- 2007-06-28
- Date terminated
- 2009-12-09
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES (K051301) | Ethicon Endo-Surgery, Inc. | 2005-08-30 |