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All Recalls

Every Arthrex, Inc. Recall

Sorted by most recent. Click any recall for full details.

21 recalls
High RiskFDA
Arthrex, Inc.
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.
Medical Devices·123 affected·Nov 2, 2022
High RiskFDA
Arthrex, Inc.
K-Wire, 1.35 mm x 170 mm
Medical Devices·300 affected·Mar 25, 2022
High RiskFDA
Arthrex, Inc.
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Medical Devices·3,985 affected·Jun 14, 2021
High RiskFDA
Arthrex, Inc.
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Medical Devices·9 affected·Feb 24, 2021
High RiskFDA
Arthrex, Inc.
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...
Medical Devices·28 affected·Jun 24, 2020
High RiskFDA
Arthrex, Inc.
Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Medical Devices·47 affected·Dec 17, 2019
High RiskFDA
Arthrex, Inc.
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 i...
Medical Devices·20 affected·Oct 1, 2019
High RiskFDA
Arthrex, Inc.
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 bot...
Medical Devices·2,324 affected·Jan 14, 2019
High RiskFDA
Arthrex, Inc.
Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Nu...
Medical Devices·1,308 affected·Nov 19, 2018
High RiskFDA
Arthrex, Inc.
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains...
Medical Implants·832 affected·Sep 13, 2018
High RiskFDA
Arthrex, Inc.
iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, ...
Medical Devices·20 affected·Oct 3, 2017
High RiskFDA
Arthrex, Inc.
Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Medical Devices·0 affected·Mar 24, 2017
High RiskFDA
Arthrex, Inc.
Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Medical Implants·0 affected·Mar 24, 2017
High RiskFDA
Arthrex, Inc.
Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Medical Devices·0 affected·Mar 24, 2017
RecallFDA
Arthrex, Inc.
Arthrex Suture Washer
Medical Devices·45 affected·Aug 12, 2016
High RiskFDA
Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and ...
Medical Devices·138 affected·Apr 22, 2016
High RiskFDA
Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and ...
Medical Devices·138 affected·Apr 22, 2016
High RiskFDA
Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and ...
Medical Devices·138 affected·Apr 22, 2016
High RiskFDA
Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and ...
Medical Devices·138 affected·Apr 22, 2016
High RiskFDA
Arthrex, Inc.
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture ...
Medical Implants·117 affected·Jan 11, 2016
High RiskFDA
Arthrex, Inc.
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 -...
Medical Implants·2,378 affected·Dec 17, 2015