FDA-Device2021-01-13Class II

Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;

Smith & Nephew, Inc.
Hazard

Manufacturing packaging error.

Sold states
Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, KY, MI, NC, NJ, OH, PA, TN, TX, WA and the countries of AU, CA & GB.
Affected count
41 units
Manufactured in
1450 E Brooks Rd, Memphis, TN, United States
Products
Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0772-2021

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