FDAFDA · Food and drugs·Recall number Z-1284-2023
G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
Published March 29, 2023 · Recall initiated: February 6, 2023
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
The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- US Distribution to states of: AZ, FL, GA, MI, NE, and TX.
- Lot
- UDI: (01)00880304703506(17)321128(10)65731960; Lot Number: 65731960
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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