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U.S. Department of Health and Human Services

Class 2 Device Recall Ethicon

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  Class 2 Device Recall Ethicon see related information
Date Initiated by Firm June 03, 2021
Create Date August 19, 2021
Recall Status1 Open3, Classified
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 2
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = Ethicon Endo-Surgery, LLC
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