FDAFDA · Food and drugs·Recall number Z-0452-2014
Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
Published December 11, 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
Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.
- Lot
- Part # 456.391S with lot numbers 5536930, exp. 5/20/2016, and 7161401, exp. 12/31/2021.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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