Smith & Nephew Recalls Mislabelled Trigen Internal Hex Reconstruction Screws
Smith & Nephew is recalling 90 units of Trigen internal hex reconstruction screws because 75 mm and 80 mm lengths were packaged in incorrect boxes and labels.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling/packaging error (length mismatch) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Smith & Nephew Inc is recalling 90 units of Trigen internal hex captured reconstruction screws (Reference 7162375) due to packaging and labeling errors. The recall involves 6.4 mm, 75 mm titanium screws used for intramedullary rod fixation.
The defect occurred because 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label. This mislabeling could lead to the use of the incorrect screw length during orthopedic procedures.
The affected batch number is 12JM17051. The products were distributed worldwide, including in the United States (specifically NM, TN, TX, NC, CA, MI, KY, MA, NJ, OH, and HI) and internationally to Canada, the United Arab Emirates, Mexico, Argentina, Japan, and Chile. Healthcare providers should stop using the affected devices and contact Smith & Nephew for further instructions.
The recalled product
- Product
- INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
- Manufacturer
- Smith & Nephew Inc
- Hazard
- Affected units
- 90
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 (1)
- Batch Number 12JM17051
Distribution
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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