Z-0724-2019 Class II Ongoing
FDA device recall Z-0724-2019 was initiated by Arthrex, Inc. on November 19, 2018 and is designated Class II. Reason for recall: Potentially lead to anchor breakage during insertion, The recall status is ongoing. Affected quantity: 1308 US and 110 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- January 23, 2019
- Initiation Date
- November 19, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1308 US and 110 OUS
Product Description
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
Reason for Recall
Potentially lead to anchor breakage during insertion,
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
Code Information
Lots #: 10175216, 1075219, 10199557, and 10199558