Class 2 Device Recall Ethicon

• Date Initiated by Firm: December 07, 2018
• Create Date: January 08, 2019
• Recall Status: Terminated on April 29, 2020
• Recall Number: Z-0695-2019
• Recall Event ID: 81773
• 510(K)Number: K030925
• Product Classification: Staple, implantable - Product Code GDW
• Product: 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.
• Code Information: Lot Codes: P9461W, P94K20
• Recalling Firm/ Manufacturer: Ethicon Endo-Surgery Inc; 4545 Creek Rd; Blue Ash OH 45242-2803
• For Additional Information Contact: SAME; 513-337-7000
• Manufacturer 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
• FDA Determined 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 Ethicon8181@stericycle.com 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
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GDW and Original Applicant = ETHICON ENDO-SURGERY, INC.