FDAFDA · Food and drugs·Recall number Z-2058-2013
Synthes Trauma Nail System. The devices are indication for bone fixation.
Published September 4, 2013 · Recall initiated: November 2, 2012
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
Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- Nationwide distribution.
- Lot
- Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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