Home / Recalls / Arthrex, Inc. / Z-0442-2019

Z-0442-2019 Class II Ongoing

Recalled by Arthrex, Inc. — Naples, FL

Recall Details

Product Type
Devices
Report Date
November 21, 2018
Initiation Date
September 13, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
832

Product Description

3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.

Reason for Recall

There is potential to break during use.

Distribution Pattern

Distributed throughout the U.S. to the following states: NC, CA, NJ, CO, NV, UT, LA, KY, OH, AZ, MO, MN, TN, NY, WI, MA, PA, TX, IL, PA, AR, FL, IA, MI, AL, SD, OR, WA, MD, KS, and GA.

Code Information

Part #ST6100, Lot/Serial #'s: A251217-04, A011217-01, A011217-03, A091017-05, A101017-01, A111017-01, A121017-01, A121017-02, A131017-01, A140917-01, A161017-01, A171017-01, A181017-07, A221117-01, A271117-01, A281117-02, A291117-01, A291117-03, A301117-01, A281117-01.

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-0724-2019 Class II — Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a (November 19, 2018)