Arthrex, Inc.

FDA Regulatory Profile

Summary

Total Recalls
28
510(k) Clearances
344
Inspections
11
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0465-2023Class IISmall Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both conNovember 2, 2022
Z-1035-2022Class IIK-Wire, 1.35 mm x 170 mmMarch 25, 2022
Z-2107-2021Class IISuture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCCJune 14, 2021
Z-1380-2021Class IITibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-uniMarch 11, 2021
Z-1310-2021Class IIDrill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle proceduresFebruary 24, 2021
Z-2733-2020Class IISterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is inteJune 24, 2020
Z-0919-2020Class IIArthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting December 17, 2019
Z-1510-2020Class IILow Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with theOctober 1, 2019
Z-1206-2019Class IIArthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resectiJanuary 14, 2019
Z-0724-2019Class IIArthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter incNovember 19, 2018
Z-0442-2019Class II3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FSeptember 13, 2018
Z-0295-2019Class IILi-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing August 27, 2018
Z-0095-2018Class IIiBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLOctober 3, 2017
Z-2042-2017Class IIAnthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-PunchingMarch 24, 2017
Z-2043-2017Class IIAnthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-PunchingMarch 24, 2017
Z-2045-2017Class IIAnthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mmMarch 24, 2017
Z-2044-2017Class IIAnthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-PunchingMarch 24, 2017
Z-2046-2017Class IIAnthrex SpeedBridge Implant System with PEEK SwiveLock Self PunchingMarch 24, 2017
Z-2041-2017Class IIAnthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-PunchingMarch 24, 2017
Z-2918-2016Class IIIArthrex Suture WasherAugust 12, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K260405FiberTape ButtonMarch 9, 2026
K252196Arthrex FibuLock Nail SystemMarch 5, 2026
K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonMarch 3, 2026
K254229Arthrex Nano FiberTak Suture AnchorMarch 2, 2026
K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemJanuary 21, 2026
K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesJanuary 12, 2026
K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmDecember 30, 2025
K253727Syndesmosis TightRope PRODecember 22, 2025
K252314Arthrex SutureTak Suture AnchorOctober 29, 2025
K251994Arthrex Synergy Vision Imaging SystemOctober 16, 2025
K251690Arthrex SpeedFLEX™ ImplantSeptember 30, 2025
K251809Arthrex FiberTak Suture AnchorJuly 18, 2025
K251145Arthrex PushLock Suture AnchorsJuly 10, 2025
K251453Arthrex iBalance Partial Knee SystemJuly 1, 2025
K243480SuturePatch Tissue ReinforcementMay 29, 2025
K250920Arthrex Spine Compression FT ScrewMay 22, 2025
K243602Arthrex Spine EndoscopeMay 16, 2025
K250728Arthrex Synergy Vision Endoscopic Imaging SystemMay 5, 2025
K250596Arthrex FiberTak Suture AnchorMarch 28, 2025
K243995Arthrex Humeral Plating System and Cerclage ButtonMarch 26, 2025