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U.S. Department of Health and Human Services

Class 3 Device Recall Suture Washer

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  Class 3 Device Recall Suture Washer see related information
Date Initiated by Firm August 12, 2016
Create Date September 30, 2016
Recall Status1 Terminated 3 on August 20, 2019
Recall Number Z-2918-2016
Recall Event ID 75050
510(K)Number K043145  
Product Classification Washer, bolt nut - Product Code HTN
Product Arthrex Suture Washer
Code Information Unique Device Identifier (UDI): 00888867118607;  Catalog # AR-7000-18T; Batch #10028617.
Recalling Firm/
Manufacturer		 Arthrex, Inc.
1370 Creekside Blvd
Naples FL 34108-1945
For Additional Information Contact Barry Dietz
239-643-5553 Ext. 1244
Manufacturer Reason
for Recall		 The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
FDA Determined
Cause 2		 Packaging process control
Action Consignees were notified 8/12/2016 of the potentially affected devices; Product/Batch Numbers: AR-7000-818T Batch #10028617. For Healthcare Professionals: immediately discontinue use of all affected products with stated numbers in their possession. Call (855) 552-5056 or email returns@arthrex.com with the product number, lot, and quantities so they may ship replacement products and expedite return of recalled product. To please complete the "Recall Acknowledgement of Receipt: postal card and return to Arthrex, Inc. Distributing Agencies: Immediately identify and hold all stated products in your inventory. Call 888-519-7255 ext. 72067 or e-mail AIM@arthrex.com Attn: Christi Zimmer. Have product number, lot number and quantities you may have so replacement product may be shipped and expedite the return of the recalled product. Please complete the "Recall Acknowledgement of Receipt" postal card and return to Arthrex. Inc. Any questions about the return of products to call 866-267-9138 and ask for Ellen Barry. Also by email to complaints@arthrez.com.
Quantity in Commerce 45 devices
Distribution OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.
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 = HTN and Original Applicant = ARTHREX, INC.
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