{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Memphis",
      "address_1": "1800 Pyramid Pl",
      "reason_for_recall": "The dovetails of poly trials, Beta 2.0,  were observed as either cracked or broken.",
      "address_2": "",
      "product_quantity": "",
      "code_info": "Lot Numbers:  a) REF 90-SRK-160310, TU53730-01  b) REF 90-SRK-160312, TU53731-01  c) REF 90-SRK-160314, TU53732-01  d) REF 90-SRK-160410, TU53730-02  e) REF 90-SRK-160412, TU53731-02  f) REF 90-SRK-160414, TU53732-02  g) REF 90-SRK-160510, TU53730-03  h) REF 90-SRK-160512, TU53731-03  i) REF 90-SRK-160514, TU53732-03  j) REF 90-SRK-160610, TU53730-04  k) REF 90-SRK-160612, TU53731-04  l) REF 90-SRK-160614, TU53732-04",
      "center_classification_date": "20170321",
      "distribution_pattern": "US distribution to AR, MA",
      "state": "TN",
      "product_description": "Poly Component Trial, CR, packaged in the following sizes and configurations:    a) Poly Component Trial - CR 3x10, REF 90-SRK-160310  b) Poly Component Trial - CR 3x12, REF 90-SRK-160312  c) Poly Component Trial - CR 3x14, REF 90-SRK-160314  d) Poly Component Trial - CR 4x10, REF 90-SRK-160410  e) Poly Component Trial - CR 4x12, REF 90-SRK-160412  f) Poly Component Trial - CR 4x14, REF 90-SRK-160414  g) Poly Component Trial - CR 5x10,REF 90-SRK-160510  h) Poly Component Trial - CR 5x12, REF 90-SRK-160512  i) Poly Component Trial - CR 5x14, REF 90-SRK-160514  j) Poly Component Trial - CR 6x10, REF 90-SRK-160610  k) Poly Component Trial - CR 6x12, REF 90-SRK-160612  l) Poly Component Trial - CR 6x14, REF 90-SRK-160614  The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint",
      "report_date": "20170329",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medtronic Sofamor Danek USA Inc",
      "recall_number": "Z-1515-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76694",
      "termination_date": "20171027",
      "more_code_info": "",
      "recall_initiation_date": "20170220",
      "postal_code": "38132-1703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}