Arthrex Recalls

19 recalls on record in the United States

medical: 19
medical Class II
2017-11-22

Arthrex, Inc. recalls iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right

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.

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medical Class II
2017-05-17

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

Some eyelets broke from SwiveLock Anchor on insertion.

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medical Class II
2017-05-17

Arthrex, Inc. recalls Anthrex SpeedBridge Implant System with BioComposite SwiveLo

Some eyelets broke from SwiveLock Anchor on insertion.

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medical Class II
2017-05-17

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

Some eyelets broke from SwiveLock Anchor on insertion.

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medical Class II
2017-05-17

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

Some eyelets broke from SwiveLock Anchor on insertion.

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medical Class II
2017-05-17

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

Some eyelets broke from SwiveLock Anchor on insertion.

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medical Class II
2017-05-17

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

Some eyelets broke from SwiveLock Anchor on insertion.

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medical Class II
2022-12-14

Arthrex, Inc. recalls Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint

The devices may be packaged with the wrong reamer size.

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medical Class II
2022-05-11

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

Products do not meet length and diameter specifications.

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medical Class II
2021-07-28

Arthrex, Inc. recalls Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, C

Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.

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medical Class II
2021-04-21

Arthrex, Inc. recalls Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Pr

It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.

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medical Class II
2021-04-07

Arthrex, Inc. recalls Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used i

The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

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medical Class II
2020-08-05

Arthrex, Inc. recalls Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number

Screws provided in packaging are 5mm shorter than intended

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medical Class II
2020-03-25

Arthrex, Inc. recalls Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4

Screws provided in the device package are 6 mm longer than intended.

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medical Class II
2020-02-05

Arthrex, Inc. recalls Arthrex Fibulock Fibular Nail Instrument Set Reusable non-s

There is a potential for blockage of the Hub Attachment Tube.

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medical Class II
2019-05-01

Arthrex, Inc. recalls Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT)

Devices may generate excessive heat during use.

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medical Class II
2019-01-23

Arthrex, Inc. recalls Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anc

Potentially lead to anchor breakage during insertion,

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medical Class II
2018-11-21

Arthrex, Inc. recalls 3.2mm Proximal Reamer/Cannulated Drill provided as part of t

There is potential to break during use.

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medical Class II
2018-11-07

Arthrex, Inc. recalls Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System

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.

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