The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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 71675207,
Manufacturer
Smith & Nephew Inc
Category
Medical Device — Orthopedic Fixation
Hazard
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 →

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