The Recall Desk

FDA (Devices) recall action 62456

Stryker Howmedica Osteonics Corp. recalled 2 products on 2012-08-01

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2012-08-01
Critical
0
Units
9,003

Why these products were recalled

Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. On June 29, 2012, Stryker has decided to remove the affected product from the field since there may be an

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.

1–2 of 2

  • HighFDA (Devices)··2012-08-01

    Stryker Recalls Rejuvenate Modular Hip Stems and Necks

    Stryker is recalling Rejuvenate Modular Hip System stems and necks due to a reported rate of less than one percent for revisions associated with fretting or corrosion.

    Product
    Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The M
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-08-01

    Stryker Recalls ABG II Modular Hip Stems for Corrosion Risk

    Stryker is recalling ABG II Modular Hip Stems to update instructions due to a reported rate of less than one percent for revisions associated with fretting and corrosion.

    Product
    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS V
    Category
    Distribution
    0 states