FDA-Device2013-07-24Class II
Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
Synthes USA HQ, Inc.
Hazard
The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.
Sold states
Nationwide Distribution including PA, CT, DE, and NY.
Affected count
10
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1726-2013Don't want to check this manually?
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