LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
type: Dataset
description: FDA recall Z-1934-2024 — CORENTEC CO., LTD is recalling LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
  type: MedicalDevice
  manufacturer: CORENTEC CO., LTD
claims: FDA recall Z-1934-2024: CORENTEC CO., LTD is recalling LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
claims: FDA classified recall Z-1934-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1934-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1934-2024
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: CORENTEC CO., LTD
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Due to unsupported 10 year expiration date.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-03-29
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 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) - S…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.
      status: recorded

FDA recall Z-1934-2024: CORENTEC CO., LTD is recalling LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
type: Claim
text: The FDA logged enforcement record Z-1934-2024: CORENTEC CO., LTD is voluntarily recalling LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert — reason: Due to unsupported 10 year expiration date.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-29. Affected lots/codes: 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 010…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-1934-2024 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.