Arthrex, Inc.
Naples, FL
This page shows every FDA and USDA recall linked to Arthrex, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
28
Total Recalls
2015
First Recall
2022
Most Recent
Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a...
Dec 8, 2022
· Device
Active
K-Wire, 1.35 mm x 170 mm
Mar 25, 2022
· Device
Active
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Jun 14, 2021
· Device
Active
Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-un...
Mar 11, 2021
· Device
Terminated
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Feb 24, 2021
· Device
Terminated
Sterile Low Profile Screw, Titanium, 6.7 x 65mm
Part Number: AR-8967-2865S - Product Usage: is intended to be...
Jun 24, 2020
· Device
Terminated
Arthrex Fibulock Fibular Nail Instrument Set
Reusable non-sterile instruments
Outrigger Targeting Guide
Dec 17, 2019
· Device
Terminated
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 Fusio...
Oct 1, 2019
· Device
Terminated
Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT)
These devices are indicated for resection of soft a...
Jan 14, 2019
· Device
Terminated
Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including sut...
Nov 19, 2018
· Device
Active
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Na...
Sep 13, 2018
· Device
Active
Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System
Product Usage:
The battery housing is used to ho...
Aug 27, 2018
· Device
Active
iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE...
Oct 3, 2017
· Device
Terminated
Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Mar 24, 2017
· Device
Terminated
Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Mar 24, 2017
· Device
Terminated
Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Mar 24, 2017
· Device
Terminated
Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Mar 24, 2017
· Device
Terminated
Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Mar 24, 2017
· Device
Terminated
Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Mar 24, 2017
· Device
Terminated
Arthrex Suture Washer
Aug 12, 2016
· Device
Terminated
BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or os...
Apr 22, 2016
· Device
Terminated
BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or os...
Apr 22, 2016
· Device
Terminated
BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or os...
Apr 22, 2016
· Device
Terminated
BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or os...
Apr 22, 2016
· Device
Terminated
BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or os...
Apr 22, 2016
· Device
Terminated
BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or os...
Apr 22, 2016
· Device
Terminated
Arthrex Deltoid Ligament Reconstruction Implant System.
Intended as a fixation post, a distribution bridge or...
Jan 11, 2016
· Device
Terminated
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Cata...
Dec 17, 2015
· Device
Terminated