{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "104904",
      "product_res_number": "Z-0416-2012",
      "event_date_initiated": "2011-08-08",
      "event_date_posted": "2012-01-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-12-08",
      "res_event_number": "60263",
      "product_code": "MBP",
      "k_numbers": [
        "K051195"
      ],
      "product_description": "Grafton DBM A-Flex; Unit Size 60 mm diam; 1ea \nContainer: Foil Pouch with Tyvek pouch\n\nFracture repair, bridge bone gaps or fragments, use with strut grafts",
      "code_info": "Catalog Number A42160 Lot #OTSCT08 2972 Exp 4/30/14",
      "firm_fei_number": "3002600221",
      "recalling_firm": "Osteotech Inc",
      "address_1": "51 James Way",
      "city": "Eatontown",
      "state": "NJ",
      "postal_code": "07724-2272",
      "additional_info_contact": "Mr. Christopher Talbot\n732-542-2800",
      "reason_for_recall": "Aseptic conditions during the production of these products may have been compromised.",
      "root_cause_description": "Material/Component Contamination",
      "action": "Osteotech sent a recall letter dated August 8, 2011, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to return all units of the affected product.  Customers were asked to contact Osteotech Customer Service at 732-578-6699 within two business days of receiving the letter to acknowledge receipt of the letter and to arrange for a return and exchange or credit for the product.\nFor questions regarding this recall call 732-542-2800.",
      "product_quantity": "18 unts",
      "distribution_pattern": "Worldwide Distribution",
      "openfda": {
        "k_number": [
          "K060180",
          "K042829",
          "K080405",
          "K242799",
          "K130703",
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          "K061668",
          "K143547",
          "K073329",
          "K050806",
          "K080329",
          "K130498",
          "K062205",
          "K060794"
        ],
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          "1000136478",
          "3006813973",
          "3000206397",
          "3009882464",
          "1220246",
          "3012447612",
          "3003828812",
          "3005064037",
          "3005031160"
        ],
        "device_name": "Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3045",
        "device_class": "2"
      }
    }
  ]
}