Arthrex 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
FDA Recall Z-0724-2019 · Posted None
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Recalling FirmArthrex, Inc.
Recall StatusOpen, Classified
Product CodeMBI
Date Initiated2018-11-19
Product Quantity1308 US and 110 OUS
Reason for Recall
Potentially lead to anchor breakage during insertion,
Firm Action
On 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 [email protected] (for direct Customers); contact [email protected] (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 [email protected].
Root Cause
Process control
Distribution Pattern
Worldwide 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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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