Home / Recalls / Arthrex, Inc. / Z-0724-2019

Z-0724-2019 Class II Ongoing

Recalled by Arthrex, Inc. — Naples, FL

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

Other recalls by Arthrex, Inc.

  • Z-0465-2023 Class II — Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-898 (November 2, 2022)
  • Z-1035-2022 Class II — K-Wire, 1.35 mm x 170 mm (March 25, 2022)
  • Z-2107-2021 Class II — Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR (June 14, 2021)
  • Z-1380-2021 Class II — Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in (March 11, 2021)
  • Z-1310-2021 Class II — Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot (February 24, 2021)
  • Z-2733-2020 Class II — Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Pr (June 24, 2020)
  • Z-0919-2020 Class II — Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments (December 17, 2019)
  • Z-1510-2020 Class II — Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545- (October 1, 2019)
  • Z-1206-2019 Class II — Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are i (January 14, 2019)
  • Z-0442-2019 Class II — 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular (September 13, 2018)