Recall Register

Food, drugs, devices › Firms

Arthrex, Inc.

FDA recalling firm · 18 enforcement events · 28 product records · 2015–2022 · FL

Arthrex, Inc. has 18 FDA enforcement events on this register (28 product records) between 2015 and 2022: 18 device; the busiest year was 2016 with 3.

0% of its events are Class I; the most common class is Class II (17). 5 events are listed as ongoing; the recalling firm's address is in FL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
2 Nov 2022Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.DeviceClass II1Ongoing
25 Mar 2022K-Wire, 1.35 mm x 170 mmDeviceClass II1Terminated
14 Jun 2021Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCCDeviceClass II1Ongoing
11 Mar 2021Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.DeviceClass II1Terminated
24 Feb 2021Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.DeviceClass II1Terminated
24 Jun 2020Sterile 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 screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.DeviceClass II1Terminated
17 Dec 2019Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting GuideDeviceClass II1Terminated
1 Oct 2019Low 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 intended to provide internal unicortical or bicortical bone fixation.DeviceClass II1Terminated
14 Jan 2019Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.DeviceClass II1Terminated
19 Nov 2018Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wristDeviceClass II1Ongoing
13 Sep 20183.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.DeviceClass II1Ongoing
27 Aug 2018Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.DeviceClass II1Ongoing
3 Oct 2017iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic…DeviceClass II1Terminated
24 Mar 2017Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-PunchingDeviceClass II6Terminated
12 Aug 2016Arthrex Suture WasherDeviceClass III1Terminated
22 Apr 2016BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.DeviceClass II6Terminated
11 Jan 2016Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.DeviceClass II1Terminated
17 Dec 2015Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the…DeviceClass II1Terminated

By type and class

Device18
Class II17
Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

15
16
17
18
19
20
21
22
23
24
25
26
Enforcement events for Arthrex, Inc. by year initiated.

Questions and answers

How many FDA recalls has Arthrex, Inc. had?

18 enforcement events (28 product records) on this register, 2015–2022: 18 device.

Are any Arthrex, Inc. recalls ongoing?

5 events are listed as ongoing in the current openFDA export.

What class are Arthrex, Inc. recalls?

17 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.