Recall Z-0724-2019 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Arthrex, Inc.
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
| Date | Nov 19, 2018 |
| Status | Open, Classified |
| Reason | Potentially lead to anchor breakage during insertion, |
| Root cause | Process control |
| 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 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 affecte |
| Quantity | 1308 US and 110 OUS |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180118 | Arthrex NanoSuture Anchor Arthrex, Inc., Feb 12, 2018 |