FDAClass IIJanuary 13, 2021

Bone fixation nail. TRIGEN INTERTAN - Product Usage recall

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;

Why was Bone fixation nail. TRIGEN INTERTAN - Product Usage recalled?

Manufacturing packaging error.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model #: 71675535 & 71675532 Lot #: 20CM25278 & 20DM01466.

Product
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;
Recalling firm
Smith & Nephew, Inc.
Quantity
41 units
Distribution
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.
Recall date
January 13, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls