Agency classClass IIOur severity:Severe FDA (Devices)·Z-1636-2014·Announced 2014-05-28

Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error

Smith & Nephew is recalling 1,253 Trigen Intertan Nails because a manufacturing error caused set screws to be inserted too deep.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or structural defects are rated as Severe (4).

Plain-English summary

Smith & Nephew Inc. is recalling 1,253 units of Trigen Intertan Nails. The recall involves specific reference numbers and lot numbers for 10 mm, 11.5 mm, and 13 mm nails in 18 cm and 20 cm lengths, with 125 and 130 degree angles.

The recall was initiated because a manufacturing error resulted in the set screw being inserted too deep in the affected nails. These are orthopedic fixation devices used in medical procedures.

The affected products were distributed worldwide, including in the USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela. Healthcare providers and patients should contact Smith & Nephew for instructions on how to handle the recalled devices.

The recalled product

Product: TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF…
Manufacturer: Smith & Nephew Inc
Category: Medical Device — Orthopedic Fixation
Hazard: manufacturing-error
structural-defect
Affected units: 1,253

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 NAIL: (1) REF 71675201
Lot Numbers: 13LT36305
13LT36306
13LT36547
13LT36548
13LT37009
13LT37010
13MT37347
13MT37665
13MT37667
13MT37668
14AT38179
14AT38180
14AT38181
14T38182
14AT38183
14AT38189
14AT38190 (2) REF 71675202
Lot Numbers: 13LT36308
13LT36549

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Smith & Nephew Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Smith & Nephew Inc

See all →

High
TRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
Moderate
Bone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
Moderate
Smith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
High
BIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
High
Smith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13

Same hazard · manufacturing error