FDA-Device2015-07-15Class II
TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.
Synthes, Inc.
Hazard
A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
Sold states
US Distribution to states of: MO and SC.
Affected count
3
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2051-2015Don't want to check this manually?
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