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U.S. Department of Health and Human Services

Class 2 Device Recall Proceed Surgical Mesh

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  Class 2 Device Recall Proceed Surgical Mesh see related information
Date Initiated by Firm October 23, 2020
Create Date December 03, 2020
Recall Status1 Terminated 3 on December 21, 2022
Recall Number Z-0533-2021
Recall Event ID 86631
510(K)Number K060713  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product PROCEED Surgical Mesh
Hernia Mesh Oval, 15 cm x 20 cm
Code Information Product Code - PCDG1 Product Lot - PHG118 GTIN Code - 10705031047716 Expiration Date: 07/31/2021
Recalling Firm/
Manufacturer		 Ethicon, Inc.
Us Highway 22 West
Somerville NJ 08876
For Additional Information Contact Stephanie Matthews
513-337-3521
Manufacturer Reason
for Recall		 The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.
FDA Determined
Cause 2		 Under Investigation by firm
Action Note: This recall is specific to this single lot of PROCEED Surgical Mesh. Health care practitioners who have treated patients using this product should follow those patients post-operatively in the usual manner with no additional action required. Product subject to the recall in your inventory can be identified by the product code information described in the above table. all unused PROCEED Surgical Mesh subject to this recall are required to be returned. Please utilize attachment 1 for assistance in identifying the product lots subject to this recall. ACTION REQUIRED: 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 recall 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 (Attachment 2) confirming receipt of this notice and return to Ethicon sales representative or distributor by [INSERT DATE]. Please return the Business Reply Form even if you do not have products subject to this recall. 5. Follow instructions in the letter and immediately return unused impacted PROCEED Surgical Mesh subject to this recall to Ethicon sales representative or distributor. To receive credit reimbursement, customers must return product subject to this recall. Any non-affected product and any product returned after the date specified will not receive credit. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Ethicon Korea. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your re
Quantity in Commerce 295 units distributed. Only 15 units are being recalled.
Distribution The impacted lot (295 units) was distributed to 27 countries worldwide excluding the US. However, the firm is only recalling the 15 units that were distributed in South Korea due to South Korea's Ministry of Food and Drug Safety (MFDS) requirements.
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 = FTL and Original Applicant = ETHICON INC.
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