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  "name": "Brand Name: Disposable Mixing Bowls with Spatula  Product Name: Mixing Bowl and Spatula  Model/Catalog Number: 00-5049-011-00  Software Version: N/A  Product Description: Mixing Bowl and Spatula  Component: N/A",
  "description": "FDA recall Z-1946-2026 — Zimmer, Inc. is recalling Brand Name: Disposable Mixing Bowls with Spatula  Product Name: Mixing Bowl and Spatula  Model/Catalog Number: 00-5049-011-00  Software Version: N/A  Product Description: Mixing Bowl and Spatula  Component: N/A (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.",
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "name": "Brand Name: Disposable Mixing Bowls with Spatula  Product Name: Mixing Bowl and Spatula  Model/Catalog Number: 00-5049-011-00  Software Version: N/A  Product Description: Mixing Bowl and Spatula  Component: N/A",
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      "name": "Zimmer, Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1946-2026/enforcement-record",
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      "name": "FDA recall Z-1946-2026: Zimmer, Inc. is recalling Brand Name: Disposable Mixing Bowls with Spatula  Product Name: Mixing Bowl and Spatula  Model/Catalog Number: 00-5049-011-00  Software Version: N/A  Product Description: Mixing Bowl and Spatula  Component: N/A",
      "text": "The FDA logged enforcement record Z-1946-2026: Zimmer, Inc. is voluntarily recalling Brand Name: Disposable Mixing Bowls with Spatula  Product Name: Mixing Bowl and Spatula  Model/Catalog Number: 00-5049-011-00  Software Version: N/A  Product Description: Mixing Bowl and Spatula  Component: N/A — reason: Ten complaints have been received identifying issues at the time of use related to the package seal,  including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-30. Affected lots/codes: Lot Code: Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)301014(10)85390029 ; Individual UDI  (01)00889024376564(17)301014(10)85390029 ; Lot Number 85390029   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)301103(10)85682882 ; Individual UDI  (01)00889024376564(17)301103(10)85682882 ; Lot Number 85682882   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)301001(10)85390028 ; Individual UDI  (01)00889024376564(17)301001(10)85390028 ; Lot Number 85390028   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300422(10)82395239 ; Individual UDI  (01)00889024376564(17)300422(10)82395239 ; Lot Number 82395239   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300423(10)82395240 ; Individual UDI  (01)00889024376564(17)300423(10)82395240 ; Lot Number 82395240   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300929(10)85390027 ; Individual UDI  (01)00889024376564(17)300929(10)85390027 ; Lot Number 85390027   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300924(10)85390026 ; Individual UDI  (01)00889024376564(17)300924(10)85390026 ; Lot Number 85390026   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300415(10)82395238 ; Individual UDI  (01)00889024376564(17)300415(10)82395238 ; Lot Number 82395238   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300922(10)85390025 ; Individual UDI  (01)00889024376564(17)300922(10)85390025 ; Lot Number 85390025   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300826(10)85390022 ; Individual UDI  (01)00889024376564(17)300826(10)85390022 ; Lot Number 85390022   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300918(10)85390024 ; Individual UDI  (01)00889024376564(17)300918(10)85390024 ; Lot Number 85390024   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300722(10)85390023 ; Individual UDI  (01)00889024376564(17)300722(10)85390023 ; Lot Number 85390023   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)310122(10)86970970 ; Individual UDI  (01)00889024376564(17)310122(10)86970970 ; Lot Number 86970970. A RECORDED FDA enforcement action (occurred=true).",
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1946-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1946-2026&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1946-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1946-2026 as Class II",
      "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.",
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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
        "operative": true
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1946-2026&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1946-2026&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1946-2026/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "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."
    }
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            "Value": "Z-1946-2026",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Zimmer, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Ten complaints have been received identifying issues at the time of use related to the package seal,  including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2026-03-30",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "Lot Code: Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)301014(10)85390029 ; Individual UDI  (01)00889024376564(17)301014(10)85390029 ; Lot Number 85390029   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)301103(10)85682882 ; Individual UDI  (01)00889024376564(17)301103(10)85682882 ; Lot Number 85682882   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)301001(10)85390028 ; Individual UDI  (01)00889024376564(17)301001(10)85390028 ; Lot Number 85390028   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300422(10)82395239 ; Individual UDI  (01)00889024376564(17)300422(10)82395239 ; Lot Number 82395239   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300423(10)82395240 ; Individual UDI  (01)00889024376564(17)300423(10)82395240 ; Lot Number 82395240   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300929(10)85390027 ; Individual UDI  (01)00889024376564(17)300929(10)85390027 ; Lot Number 85390027   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300924(10)85390026 ; Individual UDI  (01)00889024376564(17)300924(10)85390026 ; Lot Number 85390026   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300415(10)82395238 ; Individual UDI  (01)00889024376564(17)300415(10)82395238 ; Lot Number 82395238   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300922(10)85390025 ; Individual UDI  (01)00889024376564(17)300922(10)85390025 ; Lot Number 85390025   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300826(10)85390022 ; Individual UDI  (01)00889024376564(17)300826(10)85390022 ; Lot Number 85390022   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300918(10)85390024 ; Individual UDI  (01)00889024376564(17)300918(10)85390024 ; Lot Number 85390024   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)300722(10)85390023 ; Individual UDI  (01)00889024376564(17)300722(10)85390023 ; Lot Number 85390023   Model No. 00504901100 ; 20-Pack UDI  (01)00889024379718(17)310122(10)86970970 ; Individual UDI  (01)00889024376564(17)310122(10)86970970 ; Lot Number 86970970",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NM, NY, OH, OK, PA, SD, TN, TX, UT, WA, WI and the countries of Canada, Australia, New Zealand, Malaysia, EMEA, Chile.",
            "Status": "recorded"
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}