{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "161647",
      "product_res_number": "Z-0641-2018",
      "event_date_initiated": "2017-10-06",
      "event_date_created": "2018-02-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-04-03",
      "res_event_number": "79205",
      "product_code": "JEB",
      "product_description": "Allen Medical Bow Frame Model A-70800.  Surgical platform used to position patients for lumbar spine procedures.",
      "code_info": "Serial Number: A402596\tA404960\tA407142\tA408656\tA411816\tA415114\tA416956 A402597\tA404961\tA407143\tA408657\tA411817\tA415115\tA416957 A402598\tA404962\tA407144\tA408658\tA411818\tA415116\tA416958 A402599\tA404963\tA407145\tA409320\tA411819\tA415117\tA416959 A402604\tA404964\tA407146\tA409321\tA411820\tA415726\tA416960 A402605\tA404965\tA407460\tA409322\tA412539\tA415727\tA416961 A402606\tA404966\tA407147\tA409323\tA412540\tA415728\tA417547 A402607\tA405472\tA407461\tA409335\tA412541\tA415729\tA417548 A402608\tA405473\tA407885\tA409336\tA412542\tA416163\tA417549 A402609\tA405474\tA407886\tA410068\tA412543\tA416164\tA417550 A402610\tA405475\tA407887\tA410069\tA412544\tA416165\tA417919 A402611\tA405476\tA407888\tA410070\tA412545\tA416166\tA543137 A403277\tA405477\tA407889\tA410071\tA412546\tA416167\t A403278\tA405478\tA407890\tA410072\tA413529\tA416168\t A403279\tA405479\tA407891\tA410073\tA413530\tA416169\t A403280\tA405787\tA407892\tA410074\tA413531\tA416170\t A403281\tA405788\tA407893\tA410075\tA413532\tA416270",
      "firm_fei_number": "1221538",
      "recalling_firm": "Allen Medical Systems",
      "address_1": "100 Discovery Way",
      "city": "Acton",
      "state": "MA",
      "postal_code": "01720-4481",
      "reason_for_recall": "The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.",
      "root_cause_description": "Device Design",
      "action": "In October of 2017 an Urgent Medical Device Correction letter was sent to customers notifying them of the recall and requesting customers to immediately remove any frames from use that are in the serial number range subject to the recall and that a service technician will coordinate correction of the device. If the device was sent to another company, to forward the recall notice o that person or  firm. If you have any questions concerning this Urgent Medical Device Correction, please contact Allen Medical Customer Service at (800) 433-5774, 8:30  5:00 pm EST.",
      "product_quantity": "161 units total",
      "distribution_pattern": "Worldwide distribution.  US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.",
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        "device_name": "Table, Surgical With Orthopedic Accessories, Manual",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4950",
        "device_class": "1"
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