FDAFDA · Food and drugs·Recall number Z-1934-2024
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
Published June 12, 2024 · Recall initiated: March 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to unsupported 10 year expiration date.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- CORENTEC CO., LTD
- Distributor
- US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Korea (the Republic of)
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