{
  "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",
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  "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": "269 units (US) 110 units (outside US)",
      "code_info": "Part Number  Lot Number  00450001100 62072174  00450001100 62248802  00450001100 62264833  00450001100 62267033  00450001100 62279041  00450001100 62279043  00450001100 62331803  00450001100 62331808  00450001100 62337755  00450001100 62343558  00450001100 62357496  00450001100 62357497  00450001100 62397412  00450001100 62397413  00450001100 62430803  00450001200 11007903  00450001200 11008443  00450001200 62168362  00450001200 62239775  00450001200 62239789  00450001200 62267626  00450001200 62267627  00450001200 62279044  00450001200 62279050  00450001600 62168363  00450001600 62239794  00450001600 62264836  00450001600 62264837  00450001600 62267631  00450001600 62290823  00450001600 62290824  00450001600 62297847  00450001600 62297848  00450001600 62310752  00450001600 62316170  00450001600 62323809  00450001600 62331810  00450001600 62337757  00450001600 62349862  00450001600 62357499  00450001600 62372416  00450001600 62405309  00450001600 62419534  00450001200 62285546  00450001200 62290833  00450001200 62290835  00450001200 62372414  00450001200 62375863  00450001200 62397414  00450001200 62405304  00450001200 62416035  00450001200 62419530  00450001200 62430804  00450001300 62160227  00450001300 62163379  00450001300 62215393  00450001300 62264834  00450001300 62267628  00450001300 62267629  00450001300 62279045  00450001300 62279051  00450001300 62285548  00450001300 62290836  00450001300 62299551  00450001300 62331811  00450001300 62337756  00450001300 62349856  00450001300 62349857  00450001300 62368383  00450001300 62375865  00450001300 62375868  00450001300 62378060  00450001300 62397415  00450001300 62397416  00450001300 62409032  00450001300 62409033  00450001300 62416036  00450001300 62419532  00450001300 62430805  00450001400 11007904  00450001400 11008529  00450001400 62163382  00450001400 62208153  00450001400 62239776  00450001400 62239786  00450001400 62264835  00450001400 62279052  00450001400 62290829  00450001400 62299552  00450001400 62305739  00450001400 62310750  00450001400 62316168  00450001400 62316169  00450001400 62343549  00450001400 62343550  00450001400 62343551  00450001400 62349858  00450001400 62368384  00450001400 62372415  00450001400 62378062  00450001400 62393803  00450001400 62393804  00450001400 62397417  00450001400 62405306  00450001400 62409034  00450001400 62416038  00450001400 62416039  00450001400 62416040  00450001400 62419533  00450001400 62459855  00450001500 62072172  00450001500 62208154  00450001500 62215392  00450001500 62220672  00450001500 62220674  00450001500 62226570  00450001500 62279046  00450001500 62279053  00450001500 62285550  00450001500 62290842  00450001500 62331809  00450001500 62349859  00450001500 62349861  00450001500 62357498  00450001500 62358906  00450001500 62378063  00450001500 62393805  00450001500 62397418  00450001500 62405308  00450001500 62416042  00450001500 62439673  00450001600 11007906  Part Number  Lot Number  00830001100 62264850  00830001100 62316172  00830001100 62323776  00830001100 62337212  00830001100 62357509  00830001200 62204729  00830001200 62215395  00830001200 62316173  00830001200 62323778  00830001200 62331816  00830001200 62343559  00830001300 11008422  00830001300 62204730  00830001300 62220676  00830001300 62267038  00830001300 62267040  00830001300 62323781  00830001300 62331817  00830001300 62337216  00830001300 62349869  00830001300 62409040  00830001400 62208150  00830001400 62264851  00830001400 62310756  00830001400 62316177  00830001400 62323783  00830001400 62343560  00830001400 62343561  00830001400 62368388  00830001500 62204731  00830001500 62215396  00830001500 62305743  00830001500 62323784  00830001500 62343563  00830001500 62357510  00830001500 62428994  00830001600 62264852  00830001600 62299553  00830001600 62316174  00830001600 62323786  00830001600 62337210  00830001600 62343565  00830001600 62357511",
      "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 Talar Component Left 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-0475-2014",
      "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"
    }
  ]
}