FDAFDA · Food and drugs·Recall number Z-0843-2024
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Published February 7, 2024 · Recall initiated: August 8, 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
Centered glenosphere box may contain an eccentric glenosphere.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- FX SHOULDER
- Distributor
- US Nationwide distribution in the state of NJ.
- Lot
- UDI-DI: 03701037309551, Lot: U0191
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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