{
  "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": {
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  "results": [
    {
      "country": "United States",
      "city": "Plymouth",
      "address_1": "2300 Berkshire Ln N",
      "reason_for_recall": "On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using the sterilization parameters identified in the Standard Offset Cup Impactor\u0019s Instructions for Use (IFU).",
      "address_2": "",
      "product_quantity": "4478 (2906 US, 1572 OUS)",
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      "center_classification_date": "20161129",
      "distribution_pattern": "Worldwide Distribution - US including CA, IN, KS,NJ, NC, TN, TX, and UT and Internationally to ITALY, JAPAN, FRANCE, SPAIN, GERMANY, NETHERLANDS, GREECE, LUXEMBOURG, SOUTH KOREA, IRELAND, UNITED KINGDOM, AUSTRALIA, AUSTRIA, BELGIUM, SWITZERLAND, NORWAY, SWEDEN, and TAIWAN.",
      "state": "MN",
      "product_description": "Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #:   Tl0600 ~ MMP3100CHA04  T10491 MIMP3100CHA04  T12230 M2M1P3100CHA04  T15752 ~MMP3100CHA04  T15949 ~MMP3100CHA04  T17238   MMP3100CHA04  T9954     MMP3100CHA04  T9955     MMP3100CHA04  T8468     MMP3100CHA04  T11506   MMP3100CHA13  T10281   MMP3100CHA04  T8044   ~MMP3100CHA04  T17203   87-4 20-00980  T8177 ~ MMP3100CHA04  T16934  MMP3100CHA62  Tll340 SHP9109.00010  T8043 ~ MMP3100CHA04  T17321 MMPP3100CHA04  T15311 GG920010029  T1 7650 255000110  T8143 803-t 1-103  Tl4384 EK-00200690  T1666t XEB227242  T9316 MIMP3100CHA04  Tl3642 500325  T10753 ~MMP3100CH04  T9348 ~ MMP3100CHA04  T13480  MMP3100CHA042  T10243 ~MIMP3001CHA08  Tll209 ~  MMP300CHA12  Tl0861    MMP3100CHA04  T16427   MMP3100CHA04  T9894 :-. MMP3100CHA04  T12861  MMP3100CHA\\041  T8088 2002CUPI  T1661 1 T16611  Standard Offset Cup Impactors are handheld, reusable surgical instruments used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement surgery. They are equipped with a suitable connection system to the acetabular cup (e.g. a thread) and can be supplied with a fixed or removable shock absorber. A hammer is used to deliver the necessary impact to an anvil (or impactor disc) at the rear end of the instrument.",
      "report_date": "20161207",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Greatbatch Medical",
      "recall_number": "Z-0367-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "75043",
      "termination_date": "20170727",
      "more_code_info": "",
      "recall_initiation_date": "20160802",
      "postal_code": "55441-4575",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}