FDAFDA · Food and drugs·Recall number Z-2187-2012
The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.
Published August 22, 2012 · Recall initiated: July 13, 2012
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
Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ.
- Lot
- Part number 02.03155.026, lot 2649941
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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