The Recall Desk
ModerateFDA (Devices)·Z-0772-2021·Announced 2021-01-13

Smith & Nephew Recalls Trigen Intertan Bone Fixation Nails for Packaging Error

Smith & Nephew is recalling 41 units of Trigen Intertan bone fixation nails due to a manufacturing packaging error. The devices were distributed nationwide and in Australia, Canada, and the UK.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a manufacturing packaging error. Per the rubric, this falls under 'Minor labeling errors' or 'voluntary precautionary recalls' where no specific injury or illness is reported.

Plain-English summary

Smith & Nephew, Inc. is recalling 41 units of Trigen Intertan bone fixation nails. These medical devices are indicated for the treatment of various femur fractures, including simple, comminuted, spiral, long oblique, and segmental shaft fractures. The recall is being conducted due to a manufacturing packaging error.

The affected products are identified by Model Numbers 71675535 and 71675532, and Lot Numbers 20CM25278 and 20DM01466. The devices were distributed worldwide, including across the United States in states such as Alabama, Arizona, California, Florida, Iowa, Kentucky, Michigan, North Carolina, New Jersey, Ohio, Pennsylvania, Tennessee, Texas, and Washington, as well as in Australia, Canada, and the United Kingdom.

This recall is classified as Class II by the FDA. Patients who have had these specific devices implanted should contact their healthcare provider for guidance on the appropriate next steps.

The recalled product

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;
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
41

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

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