FDAFDA · Food and drugs·Recall number Z-0493-2014
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Published January 1, 2014 · Recall initiated: November 26, 2013
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
Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide Distribution - USA Nationwide and in the countries of Europe, Italy, UK, Australia, Japan. all product in USA is under Biomet control.
- Lot
- Lot Numbers: 3070517, 3070528, 3077748, 3077750, 3077751, 3085183, 3105038, 3123395, 3123398, 3123399, 3123400, 3146439, 3165497, 3165498, 3165499, 3165500, 3181736
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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