{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bloomington",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84033",
      "recalling_firm": "Tornier, Inc",
      "address_1": "10801 Nesbitt Ave S",
      "address_2": "N/A",
      "postal_code": "55437-3109",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-0405-2020",
      "product_description": "Aequalis Ascend Flex Humeral Stem:  Part Number\tUDI  DWF601A\t3700386944475  DWF601B\t3700386944482  DWF601C\t3700386944499  DWF602A\t3700386944505  DWF602B\t3700386944512  DWF602C\t3700386944529  DWF603A\t3700386944536  DWF603B\t3700386944543  DWF603C\t3700386944550  DWF604A\t3700386944567  DWF604B\t3700386944574  DWF605A\t3700386944598  DWF605B\t3700386944604  DWF605C\t3700386944611  DWF606A\t3700386944628  DWF606B\t3700386944635  DWF606C\t3700386944642  DWF607A\t3700386944659  DWF607B\t3700386944666  DWF607C\t3700386944673  DWF608A\t3700386944680  DWF608B\t3700386944697  DWF608C\t3700386944703  DWF609A\t3700386944710  DWF609B\t3700386944727  DWF609C\t3700386944734  DWF611A\t3700386944741  DWF611B\t3700386944758  DWF611C\t3700386944765  DWF612A\t3700386944772  DWF612B\t3700386944789  DWF612C\t3700386944796  DWF613A\t3700386944802  DWF613B\t3700386944819  DWF613C\t3700386944826  DWF614A\t3700386944833  DWF614B\t3700386944840  DWF614C\t3700386944857  DWF615A\t3700386944864  DWF615B\t3700386944871  DWF615C\t3700386944888  DWF616A\t3700386944895  DWF616B\t3700386944901  DWF616C\t3700386944918  DWF617A\t3700386944925  DWF617B\t3700386944932  DWF617C\t3700386944949  DWF618A\t3700386944956  DWF618B\t3700386944963  DWF618C\t3700386944970  DWF619A\t3700386944987  DWF619B\t3700386944994  DWF619C\t3700386945007  DWF702A\t3700386945045  DWF702B\t3700386945052  DWF702C\t3700386945069  DWF703A\t3700386945076  DWF703B\t3700386945083  DWF703C\t3700386945090  DWF704A\t3700386945106  DWF704B\t3700386945113  DWF704C\t3700386945120  DWF705A\t3700386945137  DWF705B\t3700386945144  DWF705C\t3700386945151  DWF706A\t3700386945168  DWF706B\t3700386945175  DWF706C\t3700386945182  DWF707A\t3700386945199  DWF707B\t3700386945205  DWF707C\t3700386945212  DWF708A\t3700386945229  DWF708B\t3700386945236  DWF708C\t3700386945243  DWF709A\t3700386945250  DWF709B\t3700386945267  DWF709C\t3700386945274  DWF712A\t3700386945311  DWF712B\t3700386945328  DWF712C\t3700386945335  DWF713A\t3700386945342  DWF713B\t3700386945359  DWF713C\t3700386945366  DWF714A\t3700386945373  DWF714B\t3700386945380  DWF714C\t3700386945397  DWF715A\t3700386945403  DWF715B\t3700386945410  DWF715C\t3700386945427  DWF716A\t3700386945434  DWF716B\t3700386945441  DWF716C\t3700386945458  DWF717A\t3700386945465  DWF717B\t3700386945472  DWF717C\t3700386945489  DWF718A\t3700386945496  DWF718B\t3700386945502  DWF718C\t3700386945519  DWF719A\t3700386945526  DWF719B\t3700386945533  DWF719C\t3700386945540    Product Usage: The AEQUALIS ASCEND FLEX Convertible Shoulder System is intended for use as:   A replacement of shoulder joints in primary anatomic or primary reverse.   A replacement of other shoulder joint devices in case of revisions, if sufficient bone stock remains.   The AEQUALIS ASCEND FLEX Convertible Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.",
      "product_quantity": "87869 units",
      "reason_for_recall": "During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints.  Movement within the packaging may cause the product to rub against the PETG blister shipping container causing the transfer of PETG material from the blister container to the stem.",
      "recall_initiation_date": "20191018",
      "center_classification_date": "20191114",
      "termination_date": "20210409",
      "report_date": "20191120",
      "code_info": "All Lot/Serial Numbers"
    }
  ]
}