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.

26–28 of 28

  • HighFDA (Devices)·Z-1959-2016·2016-06-22

    Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to a potential for polystyrene particulate presence.

    Product
    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.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1360-2016·2016-04-20

    Arthrex Deltoid Ligament Implant Recalled for Potential Sterility Issue

    Arthrex is recalling 117 Deltoid Ligament Reconstruction Implant Systems because a component may not be sterile.

    Product
    Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1195-2016·2016-03-30

    Arthrex Recalls IBalance TKA Tibial Trays Due to Surface Texture Defect

    Arthrex, Inc. is recalling 2,378 IBalance TKA Tibial Trays because the outer metal surface is smooth instead of textured. The devices were distributed nationwide.

    Product
    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 # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for imp
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.