FDA-Device2013-12-04Class II

Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

Synthes USA HQ, Inc.
Hazard

The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.

Sold states
Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.
Affected count
14
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0407-2014

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