Home / Recalls / Arthrex, Inc. / Z-1380-2021

Z-1380-2021 Class II Terminated

Recalled by Arthrex, Inc. — Naples, FL

Recall Details

Product Type
Devices
Report Date
April 21, 2021
Initiation Date
March 11, 2021
Termination Date
October 29, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32 units

Product Description

Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.

Reason for Recall

It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.

Code Information

Part number: AR-13200T-15.0; Lot code:12135408

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-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)
  • Z-0442-2019 Class II — 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular (September 13, 2018)