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.
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 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. Ortho
- Manufacturer
- Smith & Nephew Inc
- 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 (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.
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