FDAFDA · Food and drugs·Recall number Z-0219-2015
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
Published November 26, 2014 · Recall initiated: October 29, 2014
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 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- US Distribution in the states of: AK, FL, OH, OK, and TX.
- Lot
- part number: 456.316S, lot number: 7782247
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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