FDA-Device2013-03-20Class II
Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Synthes USA HQ, Inc.
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.
Sold states
Worldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland.
Affected count
596
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0942-2013Don't want to check this manually?
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