{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Foothill Ranch",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80520",
      "recalling_firm": "Ossur Americas",
      "address_1": "27051 Towne Centre Dr",
      "address_2": "N/A",
      "postal_code": "92610-2804",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA;    Foreign: Australia, Germany, New Zealand, Belgium",
      "recall_number": "Z-0997-2019",
      "product_description": "Ossur Skull Pin, Sterile Titanium Pin,    Part/Description:   516TS/ Skull Pin 2-1/4in TI Sterl 1PK;  516V2S/ Skull Pin 3in TI Sterl 1PK;  520TS/ Skull Pin 2-1/4in TI Sterl 5PK;  520V2S/ Skull Pin 3in TI Sterl 5 PK",
      "product_quantity": "372",
      "reason_for_recall": "Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.",
      "recall_initiation_date": "20180621",
      "center_classification_date": "20190311",
      "termination_date": "20200904",
      "report_date": "20190320",
      "code_info": "All lots of the products manufactured from 06/30/2009 - 12/13/2018    Titanium Pin Label Mistakenly lists Ceramic Tip, Part/Lot numbers: 516TS/ AL18021418 and AL17022109; 520TS/ AL18021417 and AL15091012"
    }
  ]
}