{
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        "reason": "Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue."
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      {
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        "reason": "Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting\ntogether properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance."
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      {
        "resNumber": "Z-0706-2022",
        "productCode": "KWP",
        "status": "Open, Classified",
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        "initiated": "2022-01-13",
        "reason": "Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance."
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        "reason": "Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery."
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      {
        "resNumber": "Z-1695-2021",
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        "status": "Terminated",
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        "initiated": "2021-05-07",
        "reason": "Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm"
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  "productCodesTotal": "18",
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    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22K2M%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22K2M%2C%20Inc.%22"
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}