{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Schaumburg",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69471",
      "recalling_firm": "Instrumed International, Inc.",
      "address_1": "626 Cooper Ct",
      "address_2": "N/A",
      "postal_code": "60173-4537",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.",
      "recall_number": "Z-0539-2015",
      "product_description": "Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.",
      "product_quantity": "74 trephines",
      "reason_for_recall": "The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.",
      "recall_initiation_date": "20140908",
      "center_classification_date": "20141208",
      "termination_date": "20171129",
      "report_date": "20141217",
      "code_info": "1) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 3/16\" OD; Instrumed Product Number: 590-06491; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Michele Trephine, 6 1/4\", shaft, 3/16\" OD; Millennium Surgical Item Number: 0-48239; Lot Numbers: 020212, 120312.     2) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 3/16\" OD; Instrumed Product Number: 590-06491; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Michele Trephine, 6 1/4\", shaft, 3/16\" OD; Symmetry Surgical Item Number: 57-6305; Lot Numbers: 020212, 100111, 100213, 120312.     3) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 3/16\" OD; Instrumed Product Number: 590-06491; Trade Name: Medline Industries; Medline Industries Product Name: Michele Trephine, 6 1/4\", shaft, 3/16\" OD; Medline Industries Item Number: MDG1806301; Lot Numbers: 020212, 100111.     4) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 3/16\" OD; Instrumed Product Number: 590-06491; Trade Name: CareFusion; CareFusion Product Name: Michele Trephine, 6 1/4\", shaft, 3/16\" OD; CareFusion Item Number: VM85-1261; Lot Number: 100111.     5) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 3/16\" OD; Instrumed Product Number: 590-06491; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4\", shaft, 3/16\" OD; Boss Instruments Item Number: 74-0150; Lot Numbers: 020212, 120312.     6) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 3/16\" OD; Instrumed Product Number: 590-06491; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4\", shaft, 3/16\" OD; Boss Instruments Item Number: 74-0150; Lot Numbers: 020212, 120312.     7) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 7/32\" OD; Instrumed Product Number: 590-06496; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Michele Trephine, 6 1/4\", shaft, 7/32\" OD; Millennium Surgical Item Number: 0-48240; Lot Numbers: 010312, 090113, 120312.     8) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 7/32\" OD; Instrumed Product Number: 590-06496; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Michele Trephine, 6 1/4\", shaft, 7/32\" OD; Symmetry Surgical Item Number: 57-6306; Lot Numbers: 010312, 090113, 120312.     9) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 7/32\" OD; Instrumed Product Number: 590-06496; Trade Name: Medline Industries; Medline Industries Product Name: Michele Trephine, 6 1/4\", shaft, 7/32\" OD; Medline Industries Item Number: MDG1806306; Lot Number: 010312.     10) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 7/32\" OD; Instrumed Product Number: 590-06496; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4\", shaft, 7/32\" OD; Boss Instruments Item Number: 74-0152; Lot Numbers: 010312, 120312.     11) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 5/16\" OD; Instrumed Product Number: 590-06501; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Michele Trephine, 6 1/4\", shaft, 5/16\" OD; Millennium Surgical Item Number: 74-0152; Lot Numbers: 060213, 090411, 110412, 120312.     12) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 5/16\" OD; Instrumed Product Number: 590-06501; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Michele Trephine, 6 1/4\", shaft, 5/16\" OD; Symmetry Surgical Item Number: 57-6309; Lot Numbers: 060213, 090411, 110412, 120312.     13) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 5/16\" OD; Instrumed Product Number: 590-06501; Trade Name: Medline Industries; Medline Industries Product Name: Michele Trephine, 6 1/4\", shaft, 5/16\" OD; Medline Industries Item Number: MDG1884299; Lot Numbers: 090411.     14) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 5/16\" OD; Instrumed Product Number: 590-06501; Trade Name: Surgical Direct; Surgical Direct Product Name: Michele Trephine, 6 1/4\", shaft, 5/16\" OD; Surgical Direct Item Number: SD145691.102; Lot Numbers: 060213, 120312.     15) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 5/16\" OD; Instrumed Product Number: 590-06501; Trade Name: CareFusion; CareFusion Product Name: Michele Trephine, 6 1/4\", shaft, 5/16\" OD; CareFusion Item Number: VM85-1265; Lot Number: 090411.     16) Instrumed Product Name: Michele Trephine, 6 1/4\", shaft, 5/16\" OD; Instrumed Product Number: 590-06501; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4\", shaft, 5/16\" OD; Boss Instruments Item Number: 74-0154; Lot Numbers: 060213, 090411, 110412, 120312.     17) Instrumed Product Name: Michele Trephine 10\", customer over all length, 4.8 mm OD; Instrumed Product Number: 590-06506; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine 10\", customer over all length, 4.8 mm OD; Boss Instruments Item Number: 74-0155; Lot Number: 090411.     18) Instrumed Product Name: Michele Trephine 10\", customer over all length, 5.5 mm OD; Instrumed Product Number: 590-06506; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine 10\", customer over all length, 5.5 mm OD; Boss Instruments Item Number: 74-0156; Lot Number: 020213, 030111."
    }
  ]
}