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.
FDA Recall Z-0695-2019 · Posted None
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Recalling FirmEthicon Endo-Surgery Inc
Recall StatusTerminated
Product CodeGDW
Date Initiated2018-12-07
Date Terminated2020-04-29
Product Quantity480 units
Reason for Recall
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
Firm 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 [email protected] within three (3) business days. Please return the BRF even if you do not have the product lots subject to this recall.. Communicate the issue to relevant operating room or materials management personnel, or anyone else in the facility who needs to be informed. If any product subject to this action has been forwarded to another facility, contact that facility to arrange return.
Customers are required to return all PROXIMATE PPH Hemorrhoidal Circular Stapler products subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by April 1, 2019. Any unused Proximate PPH Hemorrhoidal Circular Stapler product lots subject to this recall returned after April 1, 2019 will not be eligible for replacement.
Contact your Ethicon sales representative or contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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