Arthrex, Inc.
Complete recall history across all FDA and CPSC categories — 28 total recalls
Arthrex, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (28)
FDA medical device enforcement actions by Arthrex, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 2, 2022 | Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-... | The devices may be packaged with the wrong reamer size. | Class II |
| Mar 25, 2022 | K-Wire, 1.35 mm x 170 mm | Products do not meet length and diameter specifications. | Class II |
| Jun 14, 2021 | Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF... | Not properly sterilized, because the outer pouch seal on the Tyvek header was... | Class II |
| Mar 11, 2021 | Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use ... | It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T... | Class II |
| Feb 24, 2021 | Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of fo... | The color indicator on the proximal end of the shaft of the AR-8770-02 is the... | Class II |
| Jun 24, 2020 | Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S -... | Screws provided in packaging are 5mm shorter than intended | Class II |
| Dec 17, 2019 | Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instrument... | There is a potential for blockage of the Hub Attachment Tube. | Class II |
| Oct 1, 2019 | Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-85... | Screws provided in the device package are 6 mm longer than intended. | Class II |
| Jan 14, 2019 | Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices ar... | Devices may generate excessive heat during use. | Class II |
| Nov 19, 2018 | Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on... | Potentially lead to anchor breakage during insertion, | Class II |
| Sep 13, 2018 | 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibul... | There is potential to break during use. | Class II |
| Aug 27, 2018 | Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage... | The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not ... | Class II |
| Oct 3, 2017 | iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR ... | Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect pa... | Class II |
| Mar 24, 2017 | Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching | Some eyelets broke from SwiveLock Anchor on insertion. | Class II |
| Mar 24, 2017 | Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching | Some eyelets broke from SwiveLock Anchor on insertion. | Class II |
| Mar 24, 2017 | Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching | Some eyelets broke from SwiveLock Anchor on insertion. | Class II |
| Mar 24, 2017 | Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching | Some eyelets broke from SwiveLock Anchor on insertion. | Class II |
| Mar 24, 2017 | Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5... | Some eyelets broke from SwiveLock Anchor on insertion. | Class II |
| Mar 24, 2017 | Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching | Some eyelets broke from SwiveLock Anchor on insertion. | Class II |
| Aug 12, 2016 | Arthrex Suture Washer | The device was assembled incorrectly. Suture and washer were not assembled; c... | Class III |
| Apr 22, 2016 | BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation ... | Potential for polystyrene particulate presence. | Class II |
| Apr 22, 2016 | BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation ... | Potential for polystyrene particulate presence. | Class II |
| Apr 22, 2016 | BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation ... | Potential for polystyrene particulate presence. | Class II |
| Apr 22, 2016 | BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation ... | Potential for polystyrene particulate presence. | Class II |
| Apr 22, 2016 | BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation ... | Potential for polystyrene particulate presence. | Class II |
| Apr 22, 2016 | BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation ... | Potential for polystyrene particulate presence. | Class II |
| Jan 11, 2016 | Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixa... | Potential for a component contained in the Implant System to be non-sterile. | Class II |
| Dec 17, 2015 | Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Cat... | Devices reported to have a smooth texture to the outer surface of the metal, ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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