FDAFDA · Food and drugs·Recall number Z-0474-2014
Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
Published December 18, 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
Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.
- Lot
- Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.