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U.S. Department of Health and Human Services

Class 2 Device Recall Arthrex Deltoid Ligament Reconstruction Implant System

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  Class 2 Device Recall Arthrex Deltoid Ligament Reconstruction Implant System see related information
Date Initiated by Firm January 11, 2016
Create Date April 08, 2016
Recall Status1 Terminated 3 on July 24, 2019
Recall Number Z-1360-2016
Recall Event ID 73579
510(K)Number K031666  
Product Classification Plate, fixation, bone - Product Code HRS
Product Arthrex Deltoid Ligament Reconstruction Implant System.

Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
Code Information Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.
Recalling Firm/
Manufacturer		 Arthrex, Inc.
1370 Creekside Blvd
Naples FL 34108-1945
For Additional Information Contact Ellen Barry
239-643-5553 Ext. 1244
Manufacturer Reason
for Recall		 Potential for a component contained in the Implant System to be non-sterile.
FDA Determined
Cause 2		 Other
Action On 01/22/2016, all distributors and end user facilities were sent an Urgent Medical Device Voluntary Recall letter by Arthrex, Inc. The firm is voluntarily recalling and replacing the referenced device. Immediately discontinue distributing and use of the indicated product and return to Arthrex. Additionally the Recall Acknowledgement of Receipt card should be completed and returned. Contact Customer Service at 800-934-4404 for replacement and return information.
Quantity in Commerce 117 devices
Distribution Distributed to the states of AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, and WI.
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 = HRS and Original Applicant = ARTHREX, INC.
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