PlainRecalls

Arthrex, Inc.

21 recalls on record · Latest: Dec 14, 2022

FDA Devices Moderate Dec 14, 2022

Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.

FDA Devices Moderate May 11, 2022

K-Wire, 1.35 mm x 170 mm

FDA Devices Moderate Jul 28, 2021

Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC

FDA Devices Moderate Apr 7, 2021

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

FDA Devices Moderate Aug 5, 2020

Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or i…

FDA Devices Moderate Mar 25, 2020

Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to p…

FDA Devices Moderate Feb 5, 2020

Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide

FDA Devices Moderate May 1, 2019

Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and …

FDA Devices Moderate Jan 23, 2019

Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317…

FDA Devices Moderate Nov 21, 2018

3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumenta…

FDA Devices Moderate Nov 22, 2017

iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicate…

FDA Devices Moderate May 17, 2017

Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

FDA Devices Moderate May 17, 2017

Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm

FDA Devices Moderate May 17, 2017

Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

FDA Devices Low Oct 12, 2016

Arthrex Suture Washer

FDA Devices Moderate Jun 22, 2016

BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

FDA Devices Moderate Jun 22, 2016

BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

FDA Devices Moderate Jun 22, 2016

BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

FDA Devices Moderate Jun 22, 2016

BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

FDA Devices Moderate Apr 20, 2016

Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over…

FDA Devices Moderate Mar 30, 2016

Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # A…