Medical DeviceDec 14, 2022
Arthrex Small Joint OATS Set, REF AR-8981-06S, 6mm recall — FDA Z-0465-2023
The devices may be packaged with the wrong reamer size.
Class IIFDA: OngoingArthrex, Inc.
Recall history in this database
Classification mix: Class II: 9.
Medical DeviceJul 28, 2021
Arthrex Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF recall — FDA Z-2107-2021
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Class IIFDA: OngoingArthrex, Inc.
Medical DeviceApr 21, 2021
Arthrex Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in recall — FDA Z-1380-2021
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
Class IIFDA: TerminatedArthrex, Inc.
Medical DeviceApr 7, 2021
Arthrex Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and recall — FDA Z-1310-2021
The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
Class IIFDA: TerminatedArthrex, Inc.
Medical DeviceAug 5, 2020
Arthrex Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product recall — FDA Z-2733-2020
Screws provided in packaging are 5mm shorter than intended
Class IIFDA: TerminatedArthrex, Inc.
Medical DeviceMar 25, 2020
Arthrex Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is recall — FDA Z-1510-2020
Screws provided in the device package are 6 mm longer than intended.
Class IIFDA: TerminatedArthrex, Inc.
Medical DeviceMay 1, 2019
Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for recall — FDA Z-1206-2019
Devices may generate excessive heat during use.
Class IIFDA: TerminatedArthrex, Inc.
Medical DeviceJan 23, 2019
Arthrex Suture Anchor, Nano Corkscrew FT recall — FDA Z-0724-2019
Potentially lead to anchor breakage during insertion,
Class IIFDA: OngoingArthrex, Inc.
Medical DeviceNov 21, 2018
Arthrex 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail recall — FDA Z-0442-2019
There is potential to break during use.
Class IIFDA: OngoingArthrex, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Arthrex, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.