FDA-Device2013-12-18Class II

Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.

Synthes USA HQ, Inc.
Hazard

Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.

Sold states
Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.
Affected count
12
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0474-2014

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