Arthrex, Inc. recalls
Every recall we track for Arthrex, Inc. — 13 in all, from 2017–2022 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
13 recalls since 2017.
All FDA recall records for Arthrex, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 0 | 3 | 0 | 3 |
| 2019 | 0 | 1 | 2 | 0 | 3 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 0 | 0 | 3 | 0 | 3 |
| 2022 | 0 | 0 | 2 | 0 | 2 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Arthrex, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Arthrex, Inc. recalls
13 shown- Lower riskMedical device
Arthrex, Inc. recalls Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a
Arthrex recalls two small joint OATS sets (6mm and 8mm) that may be packaged with the wrong reamer size. Consumers should check product labels for batch numbers to determine if affected.
ArthrexNov 2, 2022 - Lower riskMedical device
Arthrex, Inc. recalls K-Wire, 1.35 mm x 170 mm
Arthrex recalls 1.35mm x 17:00mm K-Wire products that don't meet size specs. Affected items have specific part numbers and batch codes. Consumers should check their product details.
ArthrexMar 25, 2022 - Lower riskMedical device
Arthrex, Inc. recalls Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Arthrex recalls specific suture anchors that may not be properly sterilized due to a packaging seal issue. Affected units include model AR-2323BCC with lots 12758314 and 13022357.
ArthrexJun 14, 2021 - Lower riskMedical device
Arthrex, Inc. recalls Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and
Arthrex recalls titanium tibial plates with confused part numbers that could lead to incorrect use in bone treatments. Affected items have specific part and lot codes.
ArthrexMar 11, 2021 - Lower riskMedical device
Arthrex, Inc. recalls Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Arthrex recalls 5.0mm cannulated drill bits with incorrect color indicators for foot and ankle procedures. Affected units have product code AR-8770-02 and lot number 032052.
ArthrexFeb 24, 2021 - Lower riskMedical device
Arthrex, Inc. recalls Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a
Arthrex recalls titanium screws that are 5mm shorter than labeled, potentially causing improper bone fixation. Affected products include specific part numbers for orthopedic surgery.
ArthrexJun 24, 2020 - Lower riskMedical device
Arthrex, Inc. recalls Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Arthrex recalls reusable non-sterile Fibulock Fibular Nail Instrument Set with batch 051838 due to potential hub attachment tube blockage. Affected users should contact Arthrex for details.
ArthrexDec 17, 2019 - Lower riskMedical device
Arthrex, Inc. recalls 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
Arthrex recalls Low Profile Screw (4.5x20mm, AR-8545-20) due to being 6mm longer than intended. This may cause improper bone fixation during ankle fusion surgery. Affected units have batch number 10308261.
ArthrexOct 1, 2019 - Use cautionMedical device
Arthrex, Inc. recalls Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous
Arthrex recalls oval surgical burrs (AR-8550OBT) that may overheat during arthroscopic procedures. Affected units have specific lot numbers and expiration dates.
ArthrexJan 14, 2019 - Lower riskMedical device
Arthrex, Inc. recalls Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with
Arthrex recalls Nano Corkscrew FT suture anchors due to potential breakage during insertion. Affected lots include 10175216, 1075219, 10199557, and 10199558. Learn if your product is affected and what to do.
ArthrexNov 19, 2018 - Lower riskMedical device
Arthrex, Inc. recalls 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail
Arthrex recalls 3.2mm Proximal Reamer/Cannulated Drills from FibuLock Nail System packs due to potential breakage during use. Affected units include specific part numbers and serial lots.
ArthrexSep 13, 2018 - Lower riskMedical device
Arthrex, Inc. recalls Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the
Arthrex recalls Li-ion battery housings for AR-400 DrillSaw Sports 400 systems due to potential fluid ingress. Affected units have specific batch numbers and material codes.
ArthrexAug 27, 2018 - Lower riskMedical device
Arthrex, Inc. recalls iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R,
Arthrex recalls iBalance UKA Size 3 implants with incorrect part number AR-501-UFLC on patient labels. This may lead to improper surgical use. Affected units have batch 10123297 and are prescription-only.
ArthrexOct 3, 2017
Arthrex, Inc. recall questions
How many recalls has Arthrex, Inc. had?
13 recalls from Arthrex, Inc. are on record with U.S. safety agencies, from 2017–2022.
What is the most recent Arthrex, Inc. recall?
Arthrex, Inc. recalls Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a, dated Nov 2, 2022. Every Arthrex, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Arthrex, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Arthrex, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.