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FDA (Device enforcement)Recalled 2024-03-29class ii

CORENTEC CO., LTD: LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella

Hazard

Due to unsupported 10 year expiration date.

Details from the source

Reason for recall: Due to unsupported 10 year expiration date. Distribution: US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX. Quantity: 35 Lot/code info: 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 01088063738536921729072

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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