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LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Descript...

FDA Device Recall #Z-1935-2024 — Class II — March 29, 2024

Recall Summary

Recall Number Z-1935-2024
Classification Class II — Moderate risk
Date Initiated March 29, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm CORENTEC CO., LTD
Location Cheonan, N/A
Product Type Devices
Quantity 35

Product Description

LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella

Reason for Recall

Due to unsupported 10 year expiration date.

Distribution Pattern

US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.

Lot / Code Information

Lot Code: Model No: 01.10.9XX UDI/Lot Numbers: See attached Lospa recall Attachment 1 Lospa Knee System 01.10.921 LOSPA Patella Component 26mm 0108806373833922172706281000AGEM20 00AGEM20 6/28/2027 Lospa Knee System 01.10.961 LOSPA Patella Component 30mm 0108806373833984172711281010AGHP27 10AGHP27 11/28/2027 Lospa Knee System 01.10.961 LOSPA Patella Component 30mm 0108806373833984172904281010AJDR25 10AJDR25 4/28/2029 Lospa Knee System 01.10.981 LOSPA Patella Component 32mm 0108806373834011172812281010AHL625 10AHL625 12/28/2028 Lospa Knee System 01.10.981 LOSPA Patella Component 32mm 0108806373834011172907281010AJFR25 10AJFR25 7/28/2029 Lospa Knee System 01.10.981 LOSPA Patella Component 32mm 0108806373834011172909281010AJJ528 10ajj528 9/28/2029 Lospa Knee System 01.10.9A2 LOSPA Patella Component 34mm 0108806373834059172505281010AEFC25 10AEFC25 5/28/2025 Lospa Knee System 01.10.9A2 LOSPA Patella Component 34mm 0108806373834059172805281010AHCY28 10AHCY28 5/28/2028 Lospa Knee System 01.10.9A2 LOSPA Patella Component 34mm 0108806373834059172904281010AJDR28 10AJDR28 4/28/2029 Lospa Knee System 01.10.9A2 LOSPA Patella Component 34mm 0108806373834059172907281010AJH625 10AJH625 7/28/2029 Lospa Knee System 01.10.9EC LOSPA Patella Component 38mm 0108806373853692172503281000AED827 00AED827 3/28/2025 Lospa Knee System 01.10.9EC LOSPA Patella Component 38mm 0108806373853692172603281000AFAM25 00AFAM25 3/28/2026 Lospa Knee System 01.10.9EC LOSPA Patella Component 38mm 0108806373853692172907281000AJDC25 00AJDC25 7/28/2029 Lospa Knee System 01.10.9GC LOSPA Patella Component 40mm 0108806373853708172901281000AJBC25 00AJBC25 1/28/2029

Other Recalls from CORENTEC CO., LTD

Recall # Classification Product Date
Z-1934-2024 Class II LOSPA Tibial Insert Model/Catalog Number: See ... Mar 29, 2024
Z-1454-2017 Class II Bencox Mirabo PE Liner 36/44 Model Number: H1.L... Feb 27, 2017

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.

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