The Recall Desk

FDA (Devices) recall action 91147

Howmedica Osteonics Corp. recalled 2 products on 2022-12-28

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
2022-12-28
Critical
0
Units
2,105

Why these products were recalled

Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.

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

  • ModerateFDA (Devices)··2022-12-28

    Bone Cement Recall: Missing Turkish Language Instructions for Use

    Howmedica Osteonics Corp. is recalling Full Dose CE Simplex P Single Bone Cement because the included instructions for use lack Turkish language translations. The product content itself is accurate; only the language translation is missing.

    Product
    Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-12-28

    Tobra Bone Cement Recall for Missing Turkish Instructions

    Howmedica Osteonics is recalling Tobra bone cement because packaging instructions lack Turkish language translation, though the instructions themselves are accurate. The recall affects 20 units distributed internationally.

    Product
    Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
    Category
    Distribution
    0 states