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        "reason": "As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design.  This could result in lower cutting performance."
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        "resNumber": "Z-0375-2020",
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        "reason": "As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design.  This could result in lower cutting performance."
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        "reason": "As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design.  This could result in lower cutting performance."
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      "code": "OVE",
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      "code": "LLZ",
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}
