Agency classClass IIOur severity:Severe FDA (Devices)·Z-1637-2014·Announced 2014-05-28

Smith & Nephew Recalls Trigen Intertan 1.5 Nails Due to Manufacturing Error

Smith & Nephew is recalling 1,253 units of Trigen Intertan 1.5 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 structural defects in medical devices are assigned a severity score of 4 (Severe).

Plain-English summary

Smith & Nephew Inc. is recalling 1,253 units of the Trigen Intertan 1.5 Nail, an orthopedic fixation device. The recall involves four specific reference numbers: 71676515, 71676556, 71676558, and 71676561. The affected units 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.

The recall was initiated due to a manufacturing error that resulted in the set screw being inserted too deep in the affected nails. The FDA has classified this as a Class II recall. Specific lot numbers for each reference number are listed in the official recall documentation.

Healthcare providers and patients should check their inventory and medical records for these specific reference and lot numbers. If a patient has received one of these devices, they should contact their healthcare provider for guidance on next steps.

The recalled product

Product: TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc.…
Manufacturer: Smith & Nephew Inc
Category: Medical Device — Orthopedic Fixation
Hazard: manufacturing-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 (15)

(1) REF 71676515
Lot Number 13LT36602 (2) REF 71676556
Lot Numbers: 13LT36604
13MT37354
13MT37947
14AT38705
14AT38714 (3) REF 71676558
Lot Numbers: 13KT36282
13MT37356
13MT37664
13MT37949
14AT38187 (4) REF 71676561
Lot Numbers: 13LT36605
13MT37358
14AT38188

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

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