Arthrex, Inc. recalls

28 recalls on record · latest: November 2, 2022

Official U.S. recall history for Arthrex, Inc., compiled from official government records.

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Arthrex, Inc. recalls Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulate…

November 2, 2022 · Medical device recalls Moderate risk The devices may be packaged with the wrong reamer size.

Arthrex, Inc. recalls K-Wire, 1.35 mm x 170 mm

March 25, 2022 · Medical device recalls Moderate risk Products do not meet length and diameter specifications.

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

June 14, 2021 · Medical device recalls Moderate risk Not properly sterilized, because the outer pouch seal on the Tyvek header was s…

Arthrex, Inc. recalls Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and…

March 11, 2021 · Medical device recalls Moderate risk It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-1…

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

February 24, 2021 · Medical device recalls Moderate risk The color indicator on the proximal end of the shaft of the AR-8770-02 is the i…

Arthrex, Inc. recalls Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a…

June 24, 2020 · Medical device recalls Moderate risk Screws provided in packaging are 5mm shorter than intended

Arthrex product recalled over sterility concerns

December 17, 2019 · Medical device recalls Moderate risk There is a potential for blockage of the Hub Attachment Tube.

Arthrex, Inc. recalls 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…

October 1, 2019 · Medical device recalls Moderate risk Screws provided in the device package are 6 mm longer than intended.

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

January 14, 2019 · Medical device recalls Moderate risk Devices may generate excessive heat during use.

Arthrex, Inc. recalls Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with…

November 19, 2018 · Medical device recalls Moderate risk Potentially lead to anchor breakage during insertion,

Arthrex, Inc. recalls 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedu…

September 13, 2018 · Medical device recalls Moderate risk There is potential to break during use.

Arthrex, Inc. recalls Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the ba…

August 27, 2018 · Medical device recalls Moderate risk The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not pr…

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

October 3, 2017 · Medical device recalls Moderate risk Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part…

Arthrex, Inc. recalls Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

March 24, 2017 · Medical device recalls Moderate risk Some eyelets broke from SwiveLock Anchor on insertion.

Arthrex, Inc. recalls Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm

March 24, 2017 · Medical device recalls Moderate risk Some eyelets broke from SwiveLock Anchor on insertion.

Arthrex, Inc. recalls Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

March 24, 2017 · Medical device recalls Moderate risk Some eyelets broke from SwiveLock Anchor on insertion.

Arthrex, Inc. recalls Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

March 24, 2017 · Medical device recalls Moderate risk Some eyelets broke from SwiveLock Anchor on insertion.

Arthrex, Inc. recalls Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

March 24, 2017 · Medical device recalls Moderate risk Some eyelets broke from SwiveLock Anchor on insertion.

Arthrex, Inc. recalls Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching

March 24, 2017 · Medical device recalls Moderate risk Some eyelets broke from SwiveLock Anchor on insertion.

Arthrex, Inc. recalls Arthrex Suture Washer

August 12, 2016 · Medical device recalls The device was assembled incorrectly. Suture and washer were not assembled; com…

Arthrex, Inc. recalls BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies…

April 22, 2016 · Medical device recalls Moderate risk Potential for polystyrene particulate presence.

Arthrex, Inc. recalls BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies…

April 22, 2016 · Medical device recalls Moderate risk Potential for polystyrene particulate presence.

Arthrex, Inc. recalls BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies…

April 22, 2016 · Medical device recalls Moderate risk Potential for polystyrene particulate presence.

Arthrex, Inc. recalls BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies…

April 22, 2016 · Medical device recalls Moderate risk Potential for polystyrene particulate presence.

Arthrex, Inc. recalls BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies…

April 22, 2016 · Medical device recalls Moderate risk Potential for polystyrene particulate presence.

Arthrex, Inc. recalls BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies…

April 22, 2016 · Medical device recalls Moderate risk Potential for polystyrene particulate presence.

Arthrex Deltoid Ligament Reconstruction Implant System recalled over sterility concerns

January 11, 2016 · Medical device recalls Moderate risk Potential for a component contained in the Implant System to be non-sterile.

Arthrex, Inc. recalls Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-5…

December 17, 2015 · Medical device recalls Moderate risk Devices reported to have a smooth texture to the outer surface of the metal, wh…