Agency classClass IIOur severity:High FDA (Devices)·Z-2258-2014·Announced 2014-08-27

Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error

Smith & Nephew is recalling 601 units of Trigen Intertan nails because a manufacturing error caused the proximal lag screw hole to be positioned incorrectly.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, Class II recalls without explicit reports of hospitalization or serious injury are typically scored as High (3), representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Smith & Nephew, Inc. is recalling 601 units of Trigen Intertan nails. The recall was initiated due to a manufacturing error that resulted in the proximal lag screw hole being positioned incorrectly in several batches of the product.

The affected products include various sizes and angles of Trigen Intertan nails, such as 10mm, 11.5mm, and 13mm diameters, with lengths ranging from 18cm to 46cm. The recall covers units distributed worldwide, including the United States, Australia, Canada, China, India, UAE, Japan, South Africa, South Korea, United Kingdom, Austria, Norway, Poland, and Portugal.

No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product: TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM)…
Manufacturer: Smith & Nephew, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: manufacturing-defect
Affected units: 601

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 (20)

TRIGEN INTERTAN 10MM X 18 CM NAIL
125o
REF 71675201
Lot Numbers: 14CM05726
14DM08712
14CM12004
14DM08713
14CM12005
14DM08714
14CM12006
14DM08715
14CM12008
14DM09828
14CM12009
14DM09829
14CM15434
14DM09830
14CM15435
14DM11951
14CM15438

Distribution

Distributed nationwide across the United States.

Same manufacturer · Smith & Nephew, Inc.

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