FDA-Device2014-11-26Class II
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
Synthes, Inc.
Hazard
The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.
Sold states
US Distribution in the states of: AK, FL, OH, OK, and TX.
Affected count
6
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0219-2015Don't want to check this manually?
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