FDAFDA · Food and drugs·Recall number Z-0409-2014
Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
Published December 4, 2013 · Recall initiated: July 30, 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
The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada.
- Lot
- Part No. 02.001.324, lot no. 6900823
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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