{
  "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": [
    {
      "country": "United States",
      "city": "Warsaw",
      "address_1": "345 E Main St",
      "reason_for_recall": "As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants.  The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish.  This mass media",
      "address_2": "",
      "product_quantity": "390 units (US) 129 units (outside of US)",
      "code_info": "Part Number  Lot Number  00450004100 62143211  00450004100 62215399  00450004100 62226572  00450004100 62239797  00450004100 62248808  00450004100 62285639  00450004100 62290853  00450004200 62143212  00450004200 62208157  00450004200 62208158  00450004200 62215401  00450004200 62220683  00450004200 62226573  00450004200 62248809  00450004200 62267650  00450004200 62285554  00450004200 62299545  00450004200 62393808  00450004200 62416048  00450004200 62419541  00450004300 62143213  00450004300 62160229  00450004300 62208159  00450004300 62215402  00450004300 62220681  00450004300 62220684  00450004300 62267645  00450004300 62279057  00450004300 62285555  00450004300 62285556  00450004300 62305745  00450004300 62305746  00450004300 62310757  00450004300 62349877  00450004300 62357515  00450004300 62368389  00450004300 62378070  00450004300 62397422  00450004300 62409042  00450004300 62416049  00450004300 62419542  00450004300 62442239  00450004300 62453785  00450004400 62168364  00450004400 62208160  00450004400 62215403  00450004400 62220686  00450004400 62232378  00450004400 62267647  00450004400 62297853  00450004400 62299546  00450004400 62299547  00450004400 62299548  00450004400 62343569  00450004400 62349879  00450004400 62372420  00450004400 62393809  00450004400 62397423  00450004400 62405323  00450004400 62409043  00450004500 62143215  00450004500 62215404  00450004500 62220688  00450004500 62232379  00450004500 62248810  00450004500 62254967  00450004500 62279058  00450004500 62299549  00450004500 62368390  00450004500 62378071  00450004600 62143216  00450004600 62239795  00450004600 62239796  00450004600 62248811  00450004600 62254968  00450004600 62285640  00450004600 62290855  00450004600 62405325  00830004100 62208152  00830004100 62316180  00830004100 62363978  00830004200 62204737  00830004200 62226574  00830004200 62239798  00830004200 62316181  00830004200 62337230  00830004200 62375878  00830004300 62204736  00830004300 62226575  00830004300 62232380  00830004300 62297854  00830004300 62323804  00830004300 62343570  00830004300 62372421  00830004300 62439685  00830004400 62204738  00830004400 62226576  00830004400 62232381  00830004400 62267658  00830004400 62323802  00830004400 62337231  00830004400 62375879  00830004500 62204739  00830004500 62232382  00830004500 62310759  00830004500 62331825  00830004500 62363980  00830004600 62239782  00830004600 62331826  00830004600 62357516",
      "center_classification_date": "20131210",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.",
      "state": "IN",
      "product_description": "Zimmer Trabecular Metal Total Ankle Tibial Base Component  Sizes 1-6    Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: \" Rheumatoid arthritis. \" Post-traumatic arthritis. \" Degenerative arthritis. This device is intended for cemented use only.",
      "report_date": "20131218",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Zimmer, Inc.",
      "recall_number": "Z-0477-2014",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "66717",
      "termination_date": "20141015",
      "more_code_info": "",
      "recall_initiation_date": "20131112",
      "postal_code": "46580-2746",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}