{
  "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-192310, TU53744-01  b) REF 90-SRK-191310, TU53741-01  c) REF 90-SRK-192312, TU53745-01  d) REF 90-SRK-191312, TU53742-01  e) REF 90-SRK-192314, TU53746-01  f) REF 90-SRK-191314, TU53743-01  g) REF 90-SRK-192410, TU53744-02  h) REF 90-SRK-191410, TU53741-02  i) REF 90-SRK-192412, TU53745-02  j) REF 90-SRK-191412, TU53742-02  k)  REF 90-SRK-192414, TU53746-02  l) REF 90-SRK-191414, TU53743-02  m) REF 90-SRK-192510, TU53744-03  n) REF 90-SRK-191510, TU53741-03  o)  REF 90-SRK-192512, TU53745-03  p) REF 90-SRK-191512, TU53742-03  q) REF 90-SRK-192514, TU53746-03  r) REF 90-SRK-191514, TU53743-03  s) REF 90-SRK-192610, TU53744-04  t) REF 90-SRK-191610, TU53741-04  u) REF 90-SRK-192612, TU53745-04  v) REF 90-SRK-191612, TU53742-04  w)  REF 90-SRK-192614, TU53746-04  x) REF 90-SRK-191614, TU53743-04",
      "center_classification_date": "20170321",
      "distribution_pattern": "US distribution to AR, MA",
      "state": "TN",
      "product_description": "Poly Component Trial, MPCS, packaged in the following sizes and configurations:    a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310  b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310  c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312  d) Poly Component Trial - MPCS 3x12R, REF 90-SRK-191312  e) Poly Component Trial - MPCS 3x14L, REF 90-SRK-192314  f) Poly Component Trial - MPCS 3x14R, REF 90-SRK-191314  g) Poly Component Trial - MPCS 4x10L, REF 90-SRK-192410  h) Poly Component Trial - MPCS 4x10R, REF 90-SRK-191410  i) Poly Component Trial - MPCS 4x12L, REF 90-SRK-192412  j) Poly Component Trial - MPCS 4x12R, REF 90-SRK-191412  k) Poly Component Trial - MPCS 4x14L, REF 90-SRK-192414  l) Poly Component Trial - MPCS 4x14R, REF 90-SRK-191414  m) Poly Component Trial - MPCS 5x10L, REF 90-SRK-192510  n) Poly Component Trial - MPCS 5x10R, REF 90-SRK-191510  o) Poly Component Trial - MPCS 5x12L, REF 90-SRK-192512  p) Poly Component Trial - MPCS 5x12R, REF 90-SRK-191512  q) Poly Component Trial - MPCS 5x14L, REF 90-SRK-192514  r) Poly Component Trial - MPCS 5x14R, REF 90-SRK-191514  s) Poly Component Trial - MPCS 6x10L, REF 90-SRK-192610  t) Poly Component Trial - MPCS 6x10R, REF 90-SRK-191610  u) Poly Component Trial - MPCS 6x12L, REF 90-SRK-192612  v) Poly Component Trial - MPCS 6x12R, REF 90-SRK-191612  w) Poly Component Trial - MPCS 6x14L, REF 90-SRK-192614  x) Poly Component Trial - MPCS 6x14R, REF 90-SRK-191614  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-1513-2017",
      "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"
    }
  ]
}