Device product
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
Z-0724-2019
Product summary
- Firm
- Arthrex, Inc.
- Event
- Event 81819
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1308 US and 110 OUS
- Official record key
device-enforcement:Z-0724-2019
Official wording
Reason: Potentially lead to anchor breakage during insertion,
Code information: Lots #: 10175216, 1075219, 10199557, and 10199558
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
Derived failure modes
-
Unknown
Potentially lead to anchor breakage during insertion,