EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base

FDA Device Recall #Z-0275-2023 — Class II — October 28, 2022

Recall Summary

Recall Number Z-0275-2023
Classification Class II — Moderate risk
Date Initiated October 28, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MicroPort Orthopedics Inc.
Location Arlington, TN
Product Type Devices
Quantity 24 units

Product Description

EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base

Reason for Recall

One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.

Distribution Pattern

International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.

Lot / Code Information

UDI/DI 0 0192629 08287 8, Lot 1916559

Other Recalls from MicroPort Orthopedics Inc.

Recall # Classification Product Date
Z-1133-2026 Class II Brand Name: MicroPort Product Name: HIPTURN FE... Dec 19, 2025
Z-0699-2025 Class II EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZ... Oct 29, 2024
Z-2244-2024 Class II EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-p... May 3, 2024
Z-0276-2023 Class II EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETP... Oct 28, 2022
Z-1225-2022 Class II PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD ... May 4, 2022

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.