CORENTEC CO., LTD: LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert

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: 397 Lot/code info: Lot Code: LOSPA Tibial Insert (CR) Model No: 01.10.1XX LOSPA Tibial Insert (PS) Model No: 01.10.2XX LOSPA Fixed Constrained Tibial Insert Model No: K2.IBN.4061-XXX, K2.IBN.4264-XXX, K2.IBN.4467-XXX, K2.IBN.4672-XXX, K2.IBN.4874-XXX, K2.IBN.5076-XXX, K2.IBN.5281-XXX, K2.IBN.5684-XXX UDI/Lot Numbers: See attached Lospa recall Attachment 1 Lospa Knee System 01.10.132 Lospa Tibial Insert (CR) - Size 3 / 10mm 0108806373820953172605281070AFDM33 70AFDM33 5/28/2026 Lospa Knee System 01.10.132 Lospa Tibial Insert (CR) - Size 3 / 10mm 0108806373820953172703281070AFL130 70AFL130 3/28/2027 Lospa Knee System 01.10.134 Lospa Tibial Insert (CR) - Size 3 / 12mm 0108806373820960172605281070AFDM34 70AFDM34 5/28/2026 Lospa Knee System 01.10.134 Lospa Tibial Insert (CR) - Size 3 / 12mm 0108806373820960172712281070AFL131 70AFL131 12/28/2027 Lospa Knee System 01.10.136 Lospa Tibial Insert (CR) - Size 3 / 14mm 0108806373820977172510281070AEK548 70AEK548 10/28/2025 Lospa Knee System 01.10.136 Lospa Tibial Insert (CR) - Size 3 / 14mm 0108806373820977172601281070AEK548 70AEK548 1/28/2026 Lospa Knee System 01.10.138 Lospa Tibial Insert (CR) - Size 3 / 16mm 0108806373820984172602281070AFAR33 70AFAR33 2/28/2026 Lospa Knee System 01.10.138 Lospa Tibial Insert (CR) - Size 3 / 16mm 0108806373820984172710281070AFL133 70AFL133 10/28/2027 Lospa Knee System 01.10.138 Lospa Tibial Insert (CR) - Size 3 / 16mm 0108806373820984172712281070AFL133 70AFL133 12/28/2027 Lospa Knee System 01.10.138 Lospa Tibial Insert (C

Source

Official record: FDA (Device enforcement) ↗

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