Recall archive / FDA device enforcement
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert — FDA record Z-1934-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
- Reason
- Due to unsupported 10 year expiration date.
- Classification
- Class II
- Recalling firm
- CORENTEC CO., LTD
- Quantity
- 397
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1934-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 0108806373821691172902281080AJC330 80AJC330 2/28/2029 Lospa Knee System 01.10.1B2 Lospa Tibial Insert (CR) - Size 11 / 10mm 0108806373821851172902281030AJC331 30AJC331 2/28/2029 Lospa Knee System 01.10.1B4 Lospa Tibial Insert (CR) - Size 11 / 12mm 0108806373821868172902281030AJC332 30AJC332 2/28/2029 Lospa Knee System 01.10.1C6 Lospa Tibial Insert (CR) - Size 12 / 14mm 0108806373821974172303281060accs32 60accs32 3/28/2023 Lospa Knee System 01.10.1C6 Lospa Tibial Insert (CR) - Size 12 / 14mm 0108806373821974172902281060AHH936 60AHH936 2/28/2029 Lospa Knee System 01.10.1C6 Lospa Tibial Insert (CR) - Size 12 / 14mm 0108806373821974172909281060AJK237 60AJK237 9/28/2029 Lospa Knee System 01.10.1C8 Lospa Tibial Insert (CR) - Size 12 / 16mm 0108806373821981172902281060AHA133 60AHA133 2/28/2029 Lospa Knee System 01.10.232 Lospa Tibial Insert (PS) - Size 3 / 10mm 0108806373822353172511281070AEK536 70AEK536 11/28/2025 Lospa Knee System 01.10.232 Lospa Tibial Insert (PS) - Size 3 / 10mm 0108806373822353172605281070AFDL30 70AFDL30 5/28/2026 Lospa Knee System 01.10.232 Lospa Tibial Insert (PS) - Size 3 / 10mm 0108806373822353172701281070AGA137 70AGA137 1/28/2027 Lospa Knee System 01.10.232 Lospa Tibial Insert (PS) - Size 3 / 10mm 0108806373822353172812281070AJA334 70AJA334 12/28/2028 Lospa Knee System 01.10.232 Lospa Tibial Insert (PS) - Size 3 / 10mm 0108806373822353172903281070AJD632 70AJD632 3/28/2029 Lospa Knee System 01.10.234 Lospa Tibial Insert (PS) - Size 3 / 12mm 0108806373822360172503281070AEB930 70AEB930 3/28/2025 Lospa Knee System 01.10.234 Lospa Tibial Insert (PS) - Size 3 / 12mm 0108806373822360172506281070AEDF31 70AEDF31 6/28/2025 Lospa Knee System 01.10.234 Lospa Tibial Insert (PS) - Size 3 / 12mm 0108806373822360172603281070AFD534 70AFD534 3/28/2026 Lospa Knee System 01.10.234 Lospa Tibial Insert (PS) - Size 3 / 12mm 0108806373822360172611281070AFG431 70AFG431 11/28/2026 Lospa Knee System 01.10.234 Lospa Tibial Insert (PS) - Size 3 / 12mm 0108806373822360172710281070AGL433 70AGL433 10/28/2027 Lospa Knee System 01.10.236 Lospa Tibial Insert (PS) - Size 3 / 14mm 0108806373822377172407281070ADGA32 70ADGA32 7/28/2024 Lospa Knee System 01.10.236 Lospa Tibial Insert (PS) - Size 3 / 14mm 0108806373822377172412281070AEAC32 70AEAC32 12/28/2024 Lospa Knee System 01.10.236 Lospa Tibial Insert (PS) - Size 3 / 14mm 0108806373822377172512281070AEMM32 70AEMM32 12/28/2025 Lospa Knee System 01.10.236 Lospa Tibial Insert (PS) - Size 3 / 14mm 0108806373822377172710281070AGL434 70AGL434 10/28/2027 Lospa Knee System 01.10.236 Lospa Tibial Insert (PS) - Size 3 / 14mm 0108806373822377172812281070AHBR37 70AHBR37 12/28/2028 Lospa Knee System 01.10.238 Lospa Tibial Insert (PS) - Size 3 / 16mm 0108806373822384172601281070AFAR32 70AFAR32 1/28/2026 Lospa Knee System 01.10.238 Lospa Tibial Insert (PS) - Size 3 / 16mm 0108806373822384172711281070AGLR30 70AGLR30 11/28/2027 Lospa Knee System 01.10.23A Lospa Tibial Insert (PS) - Size 3 / 18mm 0108806373822391172608281070AFH131 70AFH131 8/28/2026 Lospa Knee System 01.10.23C Lospa Tibial Insert (PS) - Size 3 / 20mm 0108806373822407172807281070AFH132 70AFH132 7/28/2028 Lospa Knee System 01.10.242 Lospa Tibial Insert (PS) - Size 4 / 10mm 0108806373822551172503281070AEB933 70AEB933 3/28/2025 Lospa Knee System 01.10.244 Lospa Tibial Insert (PS) - Size 4 / 12mm 0108806373822568172603281070AFCR38 70AFCR38 3/28/2026 Lospa Knee System 01.10.246 Lospa Tibial Insert (PS) - Size 4 / 14mm 0108806373822575172503281070AEB935 70AEB935 3/28/2025 Lospa Knee System 01.10.246 Lospa Tibial Insert (PS) - Size 4 / 14mm 0108806373822575172603281070AFCR40 70AFCR40 3/28/2026 Lospa Knee System 01.10.246 Lospa Tibial Insert (PS) - Size 4 / 14mm 0108806373822575172710281070AGEY32 70AGEY32 10/28/2027 Lospa Knee System 01.10.246 Lospa Tibial Insert (PS) - Size 4 / 14mm 0108806373822575172808281070AHBR35 70AHBR35 8/28/2028 Lospa Knee System 01.10.248 Lospa Tibial Insert (PS) - Size 4 / 16mm 0108806373822582172502281070AEB936 70AEB936 2/28/2025 Lospa Knee System 01.10.248 Lospa Tibial Insert (PS) - Size 4 / 16mm 0108806373822582172703281070AGCL37 70AGCL37 3/28/2027 Lospa Knee System 01.10.248 Lospa Tibial Insert (PS) - Size 4 / 16mm 0108806373822582172710281070AGL437 70AGL437 10/28/2027 Lospa Knee System 01.10.248 Lospa Tibial Insert (PS) - Size 4 / 16mm 0108806373822582172811281070AHK731 70AHK731 11/28/2028 Lospa Knee System 01.10.248 Lospa Tibial Insert (PS) - Size 4 / 16mm 0108806373822582172902281070AJAK35 70AJAK35 2/28/2029 Lospa Knee System 01.10.248 Lospa Tibial Insert (PS) - Size 4 / 16mm 0108806373822582172903281070AJBD37 70AJBD37 3/28/2029 Lospa Knee System 01.10.248 Lospa Tibial Insert (PS) - Size 4 / 16mm 0108806373822582172907281070AJDT32 70AJDT32 7/28/2029 Lospa Knee System 01.10.24A Lospa Tibial Insert (PS) - Size 4 / 18mm 0108806373822599172603281070AFD540 70AFD540 3/28/2026 Lospa Knee System 01.10.24A Lospa Tibial Insert (PS) - Size 4 / 18mm 0108806373822599172701281070AFLJ32 70AFLJ32 1/28/2027 Lospa Knee System 01.10.24A Lospa Tibial Insert (PS) - Size 4 / 18mm 0108806373822599172702281070AFLJ32 70AFLJ32 2/28/2027 Lospa Knee System 01.10.24A Lospa Tibial Insert (PS) - Size 4 / 18mm 0108806373822599172710281070AGL438 70AGL438 10/28/2027 Lospa Knee System 01.10.24A Lospa Tibial Insert (PS) - Size 4 / 18mm 0108806373822599172903281070AJBD38 70AJBD38 3/28/2029 Lospa Knee System 01.10.24C Lospa Tibial Insert (PS) - Size 4 / 20mm 0108806373822605172601281070AFH135 70AFH135 1/28/2026 Lospa Knee System 01.10.24C Lospa Tibial Insert (PS) - Size 4 / 20mm 0108806373822605172609281070AFH135 70AFH135 9/28/2026 Lospa Knee System 01.10.24C Lospa Tibial Insert (PS) - Size 4 / 20mm 0108806373822605172807281070AHGK30 70AHGK30 7/28/2028 Lospa Knee System 01.10.24C Lospa Tibial Insert (PS) - Size 4 / 20mm 0108806373822605172906281070AJFN30 70AJFN30 6/28/2029 Lospa Knee System 01.10.254 Lospa Tibial Insert (PS) - Size 5 / 12mm 0108806373822667172904281060AJBS31 60AJBS31 4/28/2029 Lospa Knee System 01.10.256 Lospa Tibial Insert (PS) - Size 5 / 14mm 0108806373822674172708281060AGGE37 60AGGE37 8/28/2027 Lospa Knee System 01.10.256 Lospa Tibial Insert (PS) - Size 5 / 14mm 0108806373822674172812281060AHMH30 60AHMH30 12/28/2028 Lospa Knee System 01.10.256 Lospa Tibial Insert (PS) - Size 5 / 14mm 0108806373822674172906281060AJBS32 60AJBS32 6/28/2029 Lospa Knee System 01.10.256 Lospa Tibial Insert (PS) - Size 5 / 14mm 0108806373822674172908281060AJG137 60AJG137 8/28/2029 Lospa Knee System 01.10.258 Lospa Tibial Insert (PS) - Size 5 / 16mm 0108806373822681172604281060AFDL40 60AFDL40 4/28/2026 Lospa Knee System 01.10.258 Lospa Tibial Insert (PS) - Size 5 / 16mm 0108806373822681172702281060AGB533 60AGB533 2/28/2027 Lospa Knee System 01.10.258 Lospa Tibial Insert (PS) - Size 5 / 16mm 0108806373822681172709281060AGGE38 60AGGE38 9/28/2027 Lospa Knee System 01.10.258 Lospa Tibial Insert (PS) - Size 5 / 16mm 0108806373822681172710281060AGJG36 60AGJG36 10/28/2027 Lospa Knee System 01.10.258 Lospa Tibial Insert (PS) - Size 5 / 16mm 0108806373822681172907281060AJEY35 60AJEY35 7/28/2029 Lospa Knee System 01.10.258 Lospa Tibial Insert (PS) - Size 5 / 16mm 0108806373822681172909281060AJEY35 60AJEY35 9/28/2029 Lospa Knee System 01.10.25A Lospa Tibial Insert (PS) - Size 5 / 18mm 0108806373822698172512281060AEK535 60AEK535 12/28/2025 Lospa Knee System 01.10.25A Lospa Tibial Insert (PS) - Size 5 / 18mm 0108806373822698172701281060AFLJ34 60AFLJ34 1/28/2027 Lospa Knee System 01.10.25A Lospa Tibial Insert (PS) - Size 5 / 18mm 0108806373822698172710281060AGL440 60AGL440 10/28/2027 Lospa Knee System 01.10.25A Lospa Tibial Insert (PS) - Size 5 / 18mm 0108806373822698172909281060AJKN31 60AJKN31 9/28/2029 Lospa Knee System 01.10.25C Lospa Tibial Insert (PS) - Size 5 / 20mm 0108806373822704172808281060AHHT30 60AHHT30 8/28/2028 Lospa Knee System 01.10.264 Lospa Tibial Insert (PS) - Size 6 / 12mm 0108806373822766172701281000AGB331 00AGB331 1/28/2027 Lospa Knee System 01.10.266 Lospa Tibial Insert (PS) - Size 6 /... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 12, 2024
- Recall initiation date
- Mar 29, 2024
- Center classification date
- May 31, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.