PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: January 23, 2019 Initiated: November 19, 2018 #Z-0724-2019

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,

Details

Recalling Firm
Arthrex, Inc.
Units Affected
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
Location
Naples, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by Arthrex, Inc.. Units affected: 1308 US and 110 OUS.
Why was this product recalled?
Potentially lead to anchor breakage during insertion,
Which agency issued this recall?
This recall was issued by the FDA Devices on January 23, 2019. Severity: Moderate. Recall number: Z-0724-2019.