Class 2 Device Recall Ethicon

• Date Initiated by Firm: June 03, 2021
• Create Date: August 19, 2021
• Recall Status: Terminated on September 14, 2022
• Recall Number: Z-2326-2021
• Recall Event ID: 88349
• 510(K)Number: K202665
• Product Classification: Staple, implantable - Product Code GDW
• Product: ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A
• Code Information: Lot U94V47 Exp Date: July 31, 2023 GTIN: 10705036014607
• 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: Mislabeled: Labeled on the package as 60mm contains 45mm devices
• FDA Determined Cause: Packaging change control
• Action: Ethicon notified US consignees by Urgent Medical Device removal letter on 6/3/21 via Fed-Ex second day. Ethicon Johnson & Johnson Affiliates in impacted countries will notify their customers and health authorities per their local regulations and procedures. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this action has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and email it to Ethicon at ra-ethus-fa-ss@its.jnj.com within three (3) business days. To request a copy of the BRF that may be completed and signed electronically, please email ra-ethus-fa-ss@its.jnj.com. Please return the BRF even if you do not have product subject to this recall. 5. Follow instructions in the letter and immediately return any inventory of ECHELON FLEX" Powered Plus Stapler, Product Code PSEE60A, Lot U94V47. We request that product subject to this recall be returned no later than September 10, 2021 to Ethicon. Any non-affected product and any product returned after the date specified will not receive replacement. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Ethicon. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. If you have additional questions regarding this voluntary medical device recall or require any assistance with returning product, please contact the Ethicon Res
• Quantity in Commerce: 763 eaches
• Distribution: Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom.
• 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