Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1)...

FDA Device Recall #Z-0200-2019 — Class II — September 18, 2018

Recall Summary

Recall Number Z-0200-2019
Classification Class II — Moderate risk
Date Initiated September 18, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Smith & Nephew, Inc.
Location Memphis, TN
Product Type Devices
Quantity 6 units

Product Description

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.

Reason for Recall

One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.

Distribution Pattern

US Distribution to the states of: KS and TN.

Lot / Code Information

Lot 17LM05396

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Z-0326-2025 Class II Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI... Oct 15, 2024
Z-3171-2024 Class II DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, me... Jul 9, 2024
Z-3172-2024 Class II DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, me... Jul 9, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.