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U.S. Department of Health and Human Services

Class 2 Device Recall ETHIBOND EXCEL ETHIBOND Polvester Suture

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  Class 2 Device Recall ETHIBOND EXCEL ETHIBOND Polvester Suture see related information
Date Initiated by Firm April 19, 2019
Create Date June 19, 2019
Recall Status1 Terminated 3 on February 05, 2021
Recall Number Z-1842-2019
Recall Event ID 82909
510(K)Number K946173  
Product Classification Suture, nonabsorbable, steel, monofilament and multifilament, sterile - Product Code GAQ
Product ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX
Product Code: X865W

Product Usage:
ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures
Code Information Lot Code:PBQ797 
Recalling Firm/
Manufacturer		 Ethicon, Inc.
Us Highway 22 West
Somerville NJ 08876
For Additional Information Contact SAME
908-218-0707
Manufacturer Reason
for Recall		 Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
FDA Determined
Cause 2		 Material/Component Contamination
Action Ethicon notified primary and secondary US consignees by telephone on 4/19/19 and follow-up letter dated April 24, 2019 stating reason for recall, health risk and action to take: examine inventory, remove product for return. Complete the Business Reply Form (BRF) to Stericycle at 1-844-721-3045 or ethicon5905@stericycle.com. Questions regarding this action or to report any customer complaints, please 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, 8:00 AM to 6:00 PM ET.
Quantity in Commerce 36 eaches
Distribution Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
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 = GAQ and Original Applicant = ETHICON, INC.
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