Home / Recalls / Arthrex, Inc. / Z-1310-2021

Z-1310-2021 Class II Terminated

Recalled by Arthrex, Inc. — Naples, FL

Recall Details

Product Type
Devices
Report Date
April 7, 2021
Initiation Date
February 24, 2021
Termination Date
May 2, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 units

Product Description

Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.

Reason for Recall

The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

Distribution Pattern

US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.

Code Information

Product Code AR-8770-02, Lot Number 032052

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-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-0724-2019 Class II — Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a (November 19, 2018)
  • Z-0442-2019 Class II — 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular (September 13, 2018)