LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEG...

FDA Device Recall #Z-0878-2020 — Class II — December 16, 2019

Recall Summary

Recall Number Z-0878-2020
Classification Class II — Moderate risk
Date Initiated December 16, 2019
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Smith & Nephew, Inc.
Location Memphis, TN
Product Type Devices
Quantity 59 units

Product Description

LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).

Reason for Recall

Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.

Distribution Pattern

USA: IA, NC, PA, TN. Int'l: CH, BE, GB, AE, CN, DE, NL, BR, FR.

Lot / Code Information

LEGION AP Cutting Block Size 4, Product Number 71434409, Lot Numbers: 17LM05399, 17LM07852, 17LM07852A; LEGION AP Cutting Block Size 6, Product Number 71434411, Lot Numbers: 17LM05397, 17LM05398, 17LM07849; LEGION AP Cutting Block Size 7, Product Number 71434412, Lot Numbers: 17LM01746, 17LM05390, 17LM05394, 17LM07851; LEGION AP Cutting Block Size 8, Product Number 71434413, Lot Number: 17LM08442.

Other Recalls from Smith & Nephew, Inc.

Recall # Classification Product Date
Z-0957-2026 Class II BIOSURE HA SCREW, 6MM x 20 MM. Threaded metalli... Nov 24, 2025
Z-1806-2025 Class II META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, R... Mar 18, 2025
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.