The Recall Desk

Manufacturer

Arthrex, Inc.

28 recalls in our database name Arthrex, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
28
Critical
0
Severe
2
Most recent
2022-12-14

Of the 28 recalls from Arthrex, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (7%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 28

  • HighFDA (Devices)·Z-0465-2023·2022-12-14

    Arthrex Small Joint OATS Sets recalled for incorrect reamer size packaging

    Arthrex Small Joint OATS Sets may contain the wrong size cannulated reamer. Surgeons should verify instrument sizes before use.

    Product
    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.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1035-2022·2022-05-11

    K-Wire Devices Recalled for Incorrect Length and Diameter Specifications

    Arthrex is recalling 300 K-Wire orthopedic devices that do not meet specified length and diameter requirements. Incorrect dimensions may affect surgical function.

    Product
    K-Wire, 1.35 mm x 170 mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2107-2021·2021-07-28

    Suture Anchor Products Recalled Due to Improper Sterilization

    Arthrex is recalling 3,985 BioComposite SwiveLock C suture anchors due to improper sterilization from seal defects. The affected lots (12758314 and 13022357) were distributed nationwide.

    Product
    Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1380-2021·2021-04-21

    Arthrex Recalls Tibial Opening Wedge Osteotomy Plates Due to Processing Error

    Arthrex, Inc. is recalling 32 units of Tibial Opening Wedge Osteotomy Plates because five parts were incorrectly processed as a different model.

    Product
    Tibial 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1310-2021·2021-04-07

    Arthrex Recalls Cannulated Drill Bits Due to Incorrect Color Indicator

    Arthrex, Inc. is recalling 9 units of 5.0 mm cannulated drill bits because the color indicator on the shaft is the incorrect color.

    Product
    Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2733-2020·2020-08-05

    Arthrex Recalls Sterile Low Profile Titanium Bone Screws Due to Length Error

    Arthrex, Inc. is recalling 28 units of sterile low profile titanium bone screws because the screws are 5mm shorter than intended.

    Product
    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 in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1510-2020·2020-03-25

    Arthrex Recalls Low Profile Screws Due to Incorrect Length

    Arthrex, Inc. is recalling 20 units of Low Profile Screws because they are 6 mm longer than intended. The defect may affect bone fixation.

    Product
    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 provide internal unicortical or bicortical bone fixation.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0919-2020·2020-02-05

    Arthrex Fibulock Fibular Nail Instrument Set Recalled for Potential Blockage

    Arthrex, Inc. is recalling 47 units of the Fibulock Fibular Nail Instrument Set due to a potential for blockage of the Hub Attachment Tube.

    Product
    Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1206-2019·2019-05-01

    Arthrex Burr Recalled for Excessive Heat Generation During Use

    Arthrex, Inc. is recalling specific lots of Arthrex Oval Burr devices because they may generate excessive heat during use, posing a risk of injury to patients.

    Product
    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 small articular cavities during arthroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2019·2019-01-23

    Arthrex Suture Anchor Recall Due to Potential Breakage During Insertion

    Arthrex is recalling Nano Corkscrew FT Suture Anchors because they may break during insertion. The recall covers 1,418 units distributed in the US and abroad.

    Product
    Arthrex 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 wrist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2019·2018-11-21

    Arthrex Recalls 3.2mm Proximal Reamer Due to Potential Breakage During Use

    Arthrex, Inc. is recalling 832 units of the 3.2mm Proximal Reamer/Cannulated Drill because the instrument may break during use.

    Product
    3.2mm 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, Spa
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-0295-2019·2018-11-07

    Arthrex Recalls Li-ion Battery Housings for AR-400 DrillSaw Sports 400 System

    Arthrex, Inc. is recalling 335 Li-ion Battery Housings for the AR-400 DrillSaw Sports 400 System because they may not provide a complete seal, allowing for potential fluid ingress.

    Product
    Li-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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0095-2018·2017-11-22

    Arthrex iBalance UKA Knee Implant Recalled for Incorrect Patient Labeling

    Arthrex is recalling 20 units of iBalance UKA knee implants due to incorrect part numbers and sizes printed on the patient label.

    Product
    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 Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from p
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2042-2017·2017-05-17

    Arthrex Recalls Anthrex PEEK SwiveLock SP Vented Anchors Due to Breakage

    Arthrex, Inc. is recalling specific Anthrex PEEK SwiveLock SP Vented anchors because some eyelets broke during insertion. The recall covers units distributed in the US and several international locations.

    Product
    Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2045-2017·2017-05-17

    Arthrex SpeedBridge Implant System Recalled for Broken Eyelets

    Arthrex is recalling specific SpeedBridge Implant Systems because some eyelets broke during insertion. The recall covers multiple batches distributed in the US and internationally.

    Product
    Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2041-2017·2017-05-17

    Arthrex Bio-SwiveLock SP Vented Anchor Recall Due to Broken Eyelets

    Arthrex, Inc. is recalling specific Bio-SwiveLock SP Vented anchors because some eyelets broke during insertion.

    Product
    Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2043-2017·2017-05-17

    Arthrex Bio Composite SwiveLock Anchor Eyelets Break on Insertion

    Arthrex is recalling specific batches of Bio Composite SwiveLock anchors because some eyelets broke during insertion.

    Product
    Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2046-2017·2017-05-17

    Arthrex Recalls Anthrex SpeedBridge Implant System Due to Broken Eyelets

    Arthrex, Inc. is recalling the Anthrex SpeedBridge Implant System because some eyelets broke from the SwiveLock Anchor during insertion.

    Product
    Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
    Category
    Medical Device
    Distribution
    49 states
  • LowFDA (Devices)·Z-2918-2016·2016-10-12

    Arthrex Suture Washer Recalled Due to Incorrect Assembly

    Arthrex, Inc. is recalling 45 Suture Washers because the suture and washer were not assembled and were placed loose in the package.

    Product
    Arthrex Suture Washer
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1961-2016·2016-06-22

    Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices were distributed in 15 states.

    Product
    BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1963-2016·2016-06-22

    Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate Presence

    Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices are used for internal bone fixation in the ankle and foot.

    Product
    BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1960-2016·2016-06-22

    Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices are used for internal bone fixation in the ankle and foot.

    Product
    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.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1958-2016·2016-06-22

    Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate

    Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate.

    Product
    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.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1962-2016·2016-06-22

    Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices were distributed in 15 states.

    Product
    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.
    Category
    Medical Device
    Distribution
    15 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Arthrex

Country
Germany
Founded
1981

Official website

Source: Wikidata (Q3577066), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.