{
  "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": "72 units",
      "code_info": "Lot Numbers:  a) REF 90-SRK-170310, TU53733-01  b) REF 90-SRK-170312, TU53736-01  c) REF 90-SRK-170314, TU53737-01  d) REF 90-SRK-170410, TU53733-02  e) REF 90-SRK-170412, TU53736-02  f) REF 90-SRK-170414, TU53737-02  g) REF 90-SRK-170510, TU53733-03  h) REF 90-SRK-170512, TU53736-03  i) REF 90-SRK-170514, TU53737-03  j) REF 90-SRK-170610, TU53733-04  k) REF 90-SRK-170612, TU53736-04  l) REF 90-SRK-170614, TU53737-04",
      "center_classification_date": "20170321",
      "distribution_pattern": "US distribution to AR, MA",
      "state": "TN",
      "product_description": "Poly Component Trial, UCCS, packaged in the following sizes and configurations:    a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310  b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312  c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314  d) Poly Comp Trial - UCCS 4x10, REF 90-SRK-170410  e) Poly Comp Trial - UCCS 4x12, REF 90-SRK-170412  f) Poly Comp Trial - UCCS 4x14, REF 90-SRK-170414  g) Poly Comp Trial - UCCS 5x10, REF 90-SRK-170510  h) Poly Comp Trial - UCCS 5x12, REF 90-SRK-170512  i) Poly Comp Trial - UCCS 5x14, REF 90-SRK-170514  j) Poly Comp Trial - UCCS 6x10, REF 90-SRK-170610  k) Poly Comp Trial - UCCS 6x12, REF 90-SRK-170612  l) Poly Comp Trial - UCCS 6x14, REF 90-SRK-170614  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-1514-2017",
      "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"
    }
  ]
}