Smith & Nephew Recalls LAG Screw Guide Pin Sleeves Due to Manufacturing Error
Smith & Nephew is recalling 116 LAG Screw 3.2mm Guide Pin Sleeves because a manufacturing error prevented the detent balls from fully compressing.
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, and the source text describes a manufacturing defect without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Smith & Nephew, Inc. is recalling 116 units of the LAG SCREW 3.2MM GUIDE PIN SLEEVE (REF 71674032). The recall is due to a manufacturing error where the detent balls in the guide pin sleeve were not drilled to the correct depth, causing them to not fully compress.
The affected devices are part of the TRIGEN InterTAN nail system, which is indicated for various femur fractures, including simple shaft, comminuted shaft, spiral shaft, long oblique shaft, and segmental shaft fractures. The recall covers batch numbers 18DM11613A, 18HM02575, 18HM13327A, and 18HM20956A.
The devices were distributed worldwide, including in the United States, Belgium, Brazil, China, Columbia, France, Great Britain, India, Japan, Russia, Singapore, South Africa, Spain, and the United Arab Emirates. Healthcare providers should stop using the affected devices and contact Smith & Nephew for further instructions.
The recalled product
- Product
- LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures…
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 116
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 (4)
- Batch Numbers: 18DM11613A
- 18HM02575
- 18HM13327A
- 18HM20956A
Distribution
Distributed nationwide across the United States.
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