FDAFDA · Food and drugs·Recall number Z-0822-2015
Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Common Name: Sirius Femoral Stem The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.
Published December 24, 2014 · Recall initiated: December 2, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 34B Catalog Number: 51-199333, Lot Number Identification: 024320 and Sirius Polish Cemented Stem 38C, Catalog Number: 51-199335, Lot Number Identification: 141680, 180920.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Foreign Distribution in China and Australia only.
- Lot
- Sirius Polish Cemented Stem 348 Catalog Number: 51-199333 Lot Number Identification: 024320
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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