Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0943-2013·Announced 2013-03-20

Smith & Nephew Recalls Mislabelled Trigen Internal Hex Reconstruction Screws

Smith & Nephew is recalling 69 Trigen internal hex reconstruction screws because 75 mm and 80 mm units were packaged in incorrect boxes and labels.

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 2/5 (Moderate).

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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling/packaging error rather than a material defect or contamination, and no injuries or illnesses are reported in the source text.

Plain-English summary

Smith & Nephew Inc. is recalling 69 units of Trigen internal hex captured reconstruction screws (Reference 7162380). The affected devices are titanium bone screws used for intramedullary rod fixation, specifically the 6.4 mm diameter, 80 mm length model. The recall involves Batch Number 12KM01206.

The recall was initiated due to a packaging and labeling error. The source text states that 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 discrepancy could lead to the implantation of a screw of the incorrect length.

The affected units were distributed worldwide, including in the United States (New Mexico, Tennessee, Texas, North Carolina, California, Michigan, Kentucky, Massachusetts, New Jersey, Ohio, and Hawaii) and internationally to Canada, the United Arab Emirates, Mexico, Argentina, Japan, and Chile. Healthcare providers and patients should verify the length of the screws against the packaging and contact Smith & Nephew for further instructions.

The recalled product

Product: INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
Manufacturer: Smith & Nephew Inc
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
packaging-error
Affected units: 69

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 12KM01206

Distribution

Distributed in 11 states:

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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