Arthrex Recalls
28 recalls on record · March 30, 2016 to December 14, 2022 · Medical Devices
Recalls by year
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18
19
20
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22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 14, 2022Medical DevicesFDA
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 cannulated
Hazard: The devices may be packaged with the wrong reamer size.
May 11, 2022Medical DevicesFDA
Arthrex, Inc. recalls K-Wire, 1.35 mm x 170 mm
Hazard: Products do not meet length and diameter specifications.
July 28, 2021Medical DevicesFDA
Arthrex, Inc. recalls Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Hazard: Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
April 21, 2021Medical DevicesFDA
Arthrex, Inc. recalls Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and f
Hazard: It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
April 7, 2021Medical DevicesFDA
Arthrex, Inc. recalls Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Hazard: The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
August 5, 2020Medical DevicesFDA
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
Hazard: Screws provided in packaging are 5mm shorter than intended
March 25, 2020Medical DevicesFDA
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 o
Hazard: Screws provided in the device package are 6 mm longer than intended.
February 5, 2020Medical DevicesFDA
Arthrex, Inc. recalls Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Hazard: There is a potential for blockage of the Hub Attachment Tube.
May 1, 2019Medical DevicesFDA
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 osseo
Hazard: Devices may generate excessive heat during use.
January 23, 2019Medical DevicesFDA
Arthrex, Inc. recalls Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with
Hazard: Potentially lead to anchor breakage during insertion,
November 21, 2018Medical DevicesFDA
Arthrex, Inc. recalls 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedu
Hazard: There is potential to break during use.
November 7, 2018Medical DevicesFDA
Arthrex, Inc. recalls Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the
Hazard: The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.
November 22, 2017Medical DevicesFDA
Arthrex, Inc. recalls iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthre
Hazard: Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 ¿UFRA, size 1 printed on the patient label inside the box.
May 17, 2017Medical DevicesFDA
Arthrex, Inc. recalls Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Hazard: Some eyelets broke from SwiveLock Anchor on insertion.
May 17, 2017Medical DevicesFDA
Arthrex, Inc. recalls Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Hazard: Some eyelets broke from SwiveLock Anchor on insertion.
May 17, 2017Medical DevicesFDA
Arthrex, Inc. recalls Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Hazard: Some eyelets broke from SwiveLock Anchor on insertion.
May 17, 2017Medical DevicesFDA
Arthrex, Inc. recalls Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Hazard: Some eyelets broke from SwiveLock Anchor on insertion.
May 17, 2017Medical DevicesFDA
Arthrex, Inc. recalls Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Hazard: Some eyelets broke from SwiveLock Anchor on insertion.
May 17, 2017Medical DevicesFDA
Arthrex, Inc. recalls Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Hazard: Some eyelets broke from SwiveLock Anchor on insertion.
October 12, 2016Medical DevicesFDA
Arthrex, Inc. recalls Arthrex Suture Washer
Hazard: The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
June 22, 2016Medical DevicesFDA
Arthrex, Inc. recalls BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies
Hazard: Potential for polystyrene particulate presence.
June 22, 2016Medical DevicesFDA
Arthrex, Inc. recalls BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies
Hazard: Potential for polystyrene particulate presence.
June 22, 2016Medical DevicesFDA
Arthrex, Inc. recalls BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies
Hazard: Potential for polystyrene particulate presence.
June 22, 2016Medical DevicesFDA
Arthrex, Inc. recalls BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies
Hazard: Potential for polystyrene particulate presence.
June 22, 2016Medical DevicesFDA
Arthrex, Inc. recalls BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies
Hazard: Potential for polystyrene particulate presence.
June 22, 2016Medical DevicesFDA
Arthrex, Inc. recalls BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies
Hazard: Potential for polystyrene particulate presence.
April 20, 2016Medical DevicesFDA
Arthrex, Inc. recalls Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for dis
Hazard: Potential for a component contained in the Implant System to be non-sterile.
March 30, 2016Medical DevicesFDA
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
Hazard: Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.