FDAFDA · Alimentos y medicamentos·N.º oficial Z-1934-2024
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
Publicado el 12 de junio de 2024 · Inicio del retiro: 29 de marzo de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Due to unsupported 10 year expiration date.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- CORENTEC CO., LTD
- Distribuidor
- US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.
- Lote
- 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 (CR) - Size 3 / 16mm 0108806373820984172801281070AFL133 70AFL133 1/28/2028 Lospa Knee System 01.10.13A Lospa Tibial Insert (CR) - Size 3 / 18mm 0108806373820991172601281070AEKE31 70AEKE31 1/28/2026 Lospa Knee System 01.10.142 Lospa Tibial Insert (CR) - Size 4 / 10mm 0108806373821158172811281070AHME32 70AHME32 11/28/2028 Lospa Knee System 01.10.142 Lospa Tibial Insert (CR) - Size 4 / 10mm 0108806373821158172812281070AJA734 70AJA734 12/28/2028 Lospa Knee System 01.10.146 Lospa Tibial Insert (CR) - Size 4 / 14mm 0108806373821172172509281070AEK632 70AEK632 9/28/2025 Lospa Knee System 01.10.146 Lospa Tibial Insert (CR) - Size 4 / 14mm 0108806373821172172602281070AFAR35 70AFAR35 2/28/2026 Lospa Knee System 01.10.146 Lospa Tibial Insert (CR) - Size 4 / 14mm 0108806373821172172803281070AHBR39 70AHBR39 3/28/2028 Lospa Knee System 01.10.148 Lospa Tibial Insert (CR) - Size 4 / 16mm 0108806373821189172512281070AELH38 70AELH38 12/28/2025 Lospa Knee System 01.10.14A Lospa Tibial Insert (CR) - Size 4 / 18mm 0108806373821196172602281070AFAR36 70AFAR36 2/28/2026 Lospa Knee System 01.10.156 Lospa Tibial Insert (CR) - Size 5 / 14mm 0108806373821271172804281060AHAA36 60AHAA36 4/28/2028 Lospa Knee System 01.10.15A Lospa Tibial Insert (CR) - Size 5 / 18mm 0108806373821295172612281060AFL143 60AFL143 12/28/2026 Lospa Knee System 01.10.178 Lospa Tibial Insert (CR) - Size 7 / 16mm 0108806373821486172812281060AHLF32 60AHLF32 12/28/2028 Lospa Knee System 01.10.17A Lospa Tibial Insert (CR) - Size 7 / 18mm 0108806373821493172710281060AFL148 60AFL148 10/28/2027 Lospa Knee System 01.10.17A Lospa Tibial Insert (CR) - Size 7 / 18mm 0108806373821493172902281060AHAJ33 60AHAJ33 2/28/2029 Lospa Knee System 01.10.17C Lospa Tibial Insert (CR) - Size 7 / 20mm 0108806373821509172804281060AHDB36 60AHDB36 4/28/2028 Lospa Knee System 01.10.184 Lospa Tibial Insert (CR) - Size 8 / 12mm 0108806373821561172807281070AHFX35 70AHFX35 7/28/2028 Lospa Knee System 01.10.194 Lospa Tibial Insert (CR) - Size 9 / 12mm 0108806373821660172602281080AFAR40 80AFAR40 2/28/2026 Lospa Knee System 01.10.196 Lospa Tibial Insert (CR) - Size 9 / 14mm 0108806373821677172605281080AFCR45 80AFCR45 5/28/2026 Lospa Knee System 01.10.196 Lospa Tibial Insert (CR) - Size 9 / 14mm 0108806373821677172902281080AJBF34 80AJBF34 2/28/2029 Lospa Knee System 01.10.198 Lospa Tibial Insert (CR) - Size 9 / 16mm 0108806373821684172902281080AJC239 80AJC239 2/28/2029 Lospa Knee System 01.10.19A Lospa Tibial Insert (CR) - Size 9 / 18mm 010880637382
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Korea (the Republic of)
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