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U.S. Department of Health and Human Services

Class 2 Device Recall Arthrex SwiveLock Anchors

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  Class 2 Device Recall Arthrex SwiveLock Anchors see related information
Date Initiated by Firm March 24, 2017
Create Date May 05, 2017
Recall Status1 Completed
Recall Number Z-2046-2017
Recall Event ID 76986
510(K)Number K101823  
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Product Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Code Information Unique Device Identifier: 00888867160231 Batch Number: 10070003 - Expiration Date 9/30/2021 
Recalling Firm/
Manufacturer
Arthrex, Inc.
1370 Creekside Blvd
Naples FL 34108-1945
Manufacturer Reason
for Recall
Some eyelets broke from SwiveLock Anchor on insertion.
FDA Determined
Cause 2
Under Investigation by firm
Action On March 24, 2017, Arthrex contacted all distributors that received potentially affected device and instructed them to place the product in quarantine. On March 27th, 2017, Distributors were instructed to return the affected device to Arthrex. Call Arthrex Customer Service at 855-552-5056 for returned goods authorization (RGA) and product return instruction. Please complete the Recall Acknowledge of Receipt postal card included in the notification. Any questions contact Complaints@Arthrex.comor 866-267-9138
Distribution AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)
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.
510(K) Database 510(K)s with Product Code = MAI and Original Applicant = ARTHREX, INC.
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