Recall Z-0695-2019 ยท GDW Staple, Implantable
Ethicon Endo-Surgery Inc
PROXIMATE HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
| Date | Dec 7, 2018 |
| Status | Terminated |
| Reason | Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired |
| Root cause | Process control |
| Action | The firm, Ethicon, issued an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" to US consignees on 12/7/18, via UPS 2nd day mail. Ethicon Johnson & Johnson Affiliates in North America (Canada), Europe, LATAM, and Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. Letter identifies reason for recall, action to be taken: examine inventory and return recalled product for replacement; complete the Business Reply Form (BRF) confirming receipt of this notice and fax or email it to Stericycle at 1-844-524-3888 or Ethicon8 |
| Quantity | 480 units |
| Distribution | Worldwide Distribution: US (Nationwide) and to countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, ECUADOR, EGYPT, INDIA, INDONESIA, JAPAN, KOREA, KUWAIT, LEBANON MEXICO, NICARAGUA, PAKISTAN, SAUDI ARABIA, SINGAPORE, TAIWAN URUGUAY and VIETNAM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030925 | PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01 Ethicon Endo-Surgery, Inc., May 15, 2003 |