FDAFDA · Food and drugs·Recall number Z-0942-2013
Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Published March 20, 2013 · Recall initiated: January 11, 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
There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- Worldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland.
- Lot
- All Lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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