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
- Company
- Arthrex, Inc.
- Recall Initiated
- November 19, 2018
- Recall Number
- Z-0724-2019
- Quantity
- 1308 US and 110 OUS
- Firm Location
- Naples, FL
Reason for Recall
Potentially lead to anchor breakage during insertion,
Distribution
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
Lot / Code Info
Lots #: 10175216, 1075219, 10199557, and 10199558
Root Cause
Process control
Action Taken
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 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.