PlainRecalls

Arthrex, Inc.

21 recalls on record · Latest: Dec 14, 2022

Arthrex, Inc. Recall Insight

Arthrex, Inc. appears on 21 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.025% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 14, 2022, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 21 entries, severity tagging shows 0 critical, 20 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 21 of 21 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (21). The date window on this page runs from Mar 30, 2016 to Dec 14, 2022.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Dec 14, 2022

Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.

FDA Devices Moderate May 11, 2022

K-Wire, 1.35 mm x 170 mm

FDA Devices Moderate Jul 28, 2021

Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC

FDA Devices Moderate Apr 7, 2021

Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.

FDA Devices Moderate Aug 5, 2020

Sterile 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 i…

FDA Devices Moderate Mar 25, 2020

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 of plates and is intended to p…

FDA Devices Moderate Feb 5, 2020

Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide

FDA Devices Moderate May 1, 2019

Arthrex 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 …

FDA Devices Moderate Jan 23, 2019

Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317…

FDA Devices Moderate Nov 21, 2018

3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumenta…

FDA Devices Moderate Nov 22, 2017

iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicate…

FDA Devices Moderate May 17, 2017

Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

FDA Devices Moderate May 17, 2017

Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm

FDA Devices Moderate May 17, 2017

Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

FDA Devices Low Oct 12, 2016

Arthrex Suture Washer

FDA Devices Moderate Jun 22, 2016

BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

FDA Devices Moderate Jun 22, 2016

BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

FDA Devices Moderate Jun 22, 2016

BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

FDA Devices Moderate Jun 22, 2016

BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

FDA Devices Moderate Apr 20, 2016

Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over…

FDA Devices Moderate Mar 30, 2016

Arthrex 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 # A…

Nearby Manufacturers

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds