The Recall Desk
HighFDA (Devices)·Z-0200-2019·Announced 2018-10-31

Smith+Nephew Legion AP Femoral Cutting Block Recalled for Oversized Spring

Smith & Nephew is recalling one lot of Legion AP femoral cutting blocks, size 6, because they were manufactured with an oversized spring.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a risk of temporary or medically reversible adverse health consequences. The source text does not report any injuries or illnesses, and the defect is a manufacturing error (oversized spring) rather than a high-risk pathogen or structural vehicle defect, placing it in the High severity category per the rubric.

Plain-English summary

Smith & Nephew, Inc. is recalling one lot of the LEGION A/P Femoral Cutting Block, size 6 (REF 71434411). The recalled product is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.

The recall was initiated because the specific lot was manufactured with an oversized spring. The agency has classified this recall as Class II.

The affected units were distributed in the United States to the states of Kansas and Tennessee. The specific lot number is 17LM05396. The source text does not specify the total number of units recalled or provide instructions for consumers or healthcare providers on how to handle the product.

The recalled product

Product
Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.
Affected units
6

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)

  • Lot 17LM05396

Distribution

Distributed in 2 states: