FDA-Device2014-08-27Class I

DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)

Synthes, Inc.
Hazard

DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively.

Sold states
US Nationwide Distribution
Affected count
1499
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2148-2014

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