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Recall Observatory FDA recall evidence

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

November 19, 2018

Class II

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

    reason.no_named_rule · v1.0.0

    Potentially lead to anchor breakage during insertion,