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U.S. Department of Health and Human Services

Class 2 Device Recall Arthrex Suture Anchor

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 Class 2 Device Recall Arthrex Suture Anchorsee related information
Date Initiated by FirmNovember 19, 2018
Create DateJanuary 11, 2019
Recall Status1 Open3, Classified
Recall NumberZ-0724-2019
Recall Event ID 81819
510(K)NumberK180118 
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
ProductArthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist
Code Information Lots #: 10175216, 1075219, 10199557, and 10199558
Recalling Firm/
Manufacturer		 Arthrex, Inc.
1370 Creekside Blvd
Naples FL 34108-1945
For Additional Information ContactArthrex Product Surveillance
866-267-9138
Manufacturer Reason
for Recall		Potentially lead to anchor breakage during insertion,
FDA Determined
Cause 2		Process control
ActionOn November 19, 2018 Arthrex sent communications to their customers indicating the following about their recall: REQUIRED ACTION BY RECIPIENT 1. Immediately discontinue use, sale, and distribution of the affected product. 2. Please contact Arthrex Product Surveillance at 866-267-9138 or complai nts@arthrex.com (for direct Customers); contact FLS@arthrex.com (for Agencies) as soon as possible to arrange for return of the affected product. Our Product Surveillance Specialists can provide assistance regarding alternative solutions and are available to answer questions regarding credit for affected devices in your possession. 3. If you are an Arthrex agency, you do not need to notify any customers as Arthrex will be notifying customers directly. 4. If you are an Arthrex customer, you do not need to notify any patients of this product recall. 5. If you have any questions about this product recall, please contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com.
Quantity in Commerce1308 US and 110 OUS
DistributionWorldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of Finland and Germany
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MBI
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