FDAFDA · Food and drugs·Recall number Z-0407-2014
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral 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 packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.
- Lot
- Part # Lot # 04.001.620S 7115414 04.001.620S 7115417 04.001.620S 7115509 04.001.620S 7115510 04.001.622S 7115533 04.001.636S 7117902 04.001.636S 7117916 04.001.638S 7117924 04.001.640S 7119089 04.001.640S 7119107 04.001.642S 7117995 04.001.642S 7119125 04.001.644S 7117998 04.001.218S 7327816 04.001.444S 7379241 04.001.620s 7265517
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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