The Recall Desk

FDA (Devices) recall action 69723

Arthrosurface, Inc. recalled 5 products on 2015-02-18

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2015-02-18
Critical
0
Units
786

Why these products were recalled

Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • ModerateFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • ModerateFDA (Devices)··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
    Distribution
    0 states
  • ModerateFDA (Devices)··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
    Distribution
    0 states
  • ModerateFDA (Devices)··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
    Distribution
    0 states