{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Boston",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78802",
      "recalling_firm": "TEI Biosciences",
      "address_1": "7 Elkins St",
      "address_2": "N/A",
      "postal_code": "02127-1601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.",
      "recall_number": "Z-0383-2018",
      "product_description": "PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.",
      "product_quantity": "4081 units",
      "reason_for_recall": "During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages:  \" 22 IFUs contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50   \" 3 IFUs were missing pages 27 - 50   \" 1 IFU was missing pages 1 - 2 & 75 - 76  \" 1 IFU was missing pages 15 - 62    While pages 27 \u0013 50, 75 \u0013 76, and 15 \u0013 62 contain instructions written in a language other than English, pages 1 \u0013 2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device.",
      "recall_initiation_date": "20170615",
      "center_classification_date": "20180117",
      "termination_date": "20180315",
      "report_date": "20180124",
      "code_info": "Product Model Number Product Lot Number Product Description Product Model Number Product Lot Number Product Description  607-004-880 1508019 8 x 8 cm 607-005-014 1702023 14mm Disc  607-005-880 1509051 8 x 8 cm 607-005-018 1702024 18mm Disc  607-005-440 1512021 4 x 4 cm 607-005-220 1702025 2 x 2 cm  607-005-812 1512022 8 x 12 cm 607-005-014 1702026 14mm Disc  607-005-440 1603044 4 x 4 cm 607-005-018 1702027 18mm Disc  607-005-660 1606038 6 x 6 cm 607-005-220 1702028 2 x 2 cm  607-001-112 1611044 10 x 12 cm 607-005-014 1702029 14mm Disc  607-001-812 1611045 8 x12 cm 607-005-018 1702030 18mm Disc  607-001-225 1612013 20 x 25 cm 607-005-220 1702031 2 x 2 cm  607-001-009 1612018 0.2 x 26.5 cm 607-005-014 1702032 14mm Disc  607-004-440 1701034 4 x 4 cm 607-005-014 1702033 14mm Disc  607-001-440 1701036 4 x 4 cm 607-005-014 1702034 14mm Disc  607-004-660 1701037 6 x 6 cm 607-005-014 1703007 14mm Disc  607-001-660 1701044 6 x 6 cm 607-005-018 1703008 18mm Disc      The affected lots are manufactured from  February 2017 to May 2017.     The affected lots will expire in 2020 to 2021."
    }
  ]
}