The Recall Desk

Manufacturer

Arthrosurface, Inc.

6 recalls in our database name Arthrosurface, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2015-12-30

Of the 6 recalls from Arthrosurface, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–6 of 6

  • HighFDA (Devices)·Z-0475-2016·2015-12-30

    Arthrosurface Total Toe Instrument Kit Recalled for Sterilization Failure

    Arthrosurface is recalling 3 Total Toe Instrument Kits because a hex driver component failed to pass half-cycle sterilization due to a design oversight.

    Product
    Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1111-2015·2015-02-18

    Arthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues

    Arthrosurface, Inc. is recalling 143 Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.

    Product
    Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1113-2015·2015-02-18

    Arthrosurface Recalls Uncleared Taper Post Fixation Components

    Arthrosurface, Inc. is recalling 182 units of Athrosurface Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.

    Product
    Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1112-2015·2015-02-18

    Arthrosurface Shoulder Prosthesis Components Recalled for Uncleared Marketing Status

    Arthrosurface, Inc. is recalling 138 Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.

    Product
    Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1114-2015·2015-02-18

    Arthrosurface Shoulder Prosthesis Components Recalled for Lack of US Clearance

    Arthrosurface, Inc. is recalling 187 units of the HHXL (OVO) 15.6x32mm Taper Post Fixation Component because the product was not cleared for marketing in the US with its current indications.

    Product
    Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1110-2015·2015-02-18

    Arthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues

    Arthrosurface, Inc. is recalling 136 units of HemiCAP shoulder prosthetic components because they were not cleared for marketing in the US with current indications.

    Product
    Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide