FDAFDA · Food and drugs·Recall number Z-0736-2023
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
Published December 28, 2022 · Recall initiated: November 7, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Howmedica Osteonics Corp.
- Distributor
- International distribution in the country of Turkey.
- Lot
- UDI# P/N 6191-0-001 (01)07613327128772 (17)261031(10)lot# GTIN: 07613327128772 -Instructions for Use (IFU) received with product: 0700-7-010 (IFU Radiopaque Bone Cement) All lots manufactured under Rev AB, with Exp. Date on/after September 16, 2021.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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