{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Memphis",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92286",
      "recalling_firm": "Smith & Nephew, Inc.",
      "address_1": "1450 E Brooks Rd",
      "address_2": "N/A",
      "postal_code": "38116-1804",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-1673-2023",
      "product_description": "Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers:    a)\tREF 1-10013-109, SIZE 1-LEFT MED, 9MM;   b)\tREF 1-10013-110, SIZE 1-LEFT MED, 10MM;   c)\tREF 1-10013-111, SIZE 1-LEFT MED, 11MM;   d)\tREF 1-10013-113, SIZE 1-LEFT MED, 13MM;   e)\tREF 1-10013-159, SIZE 1-RIGHT MED, 9MM;   f)\tREF 1-10013-160, SIZE 1-RIGHT MED, 10MM;   g)\tREF 1-10013-161, SIZE 1-RIGHT MED, 11MM;   h)\tREF 1-10013-163, SIZE 1-RIGHT MED, 13MM;   i)\tREF 1-10013-209, SIZE 2-LEFT MED, 9MM;   j)\tREF 1-10013-210, SIZE 2-LEFT MED, 10MM;   k)\tREF 1-10013-211, SIZE 2-LEFT MED, 11MM;   l)\tREF 1-10013-213, SIZE 2-LEFT MED, 13MM;   m)\tREF 1-10013-259, SIZE 2-RIGHT MED, 9MM;   n)\tREF 1-10013-260, SIZE 2-RIGHT MED, 10MM;   o)\tREF 1-10013-261, SIZE 2-RIGHT MED, 11MM;   p)\tREF 1-10013-263, SIZE 2-RIGHT MED, 13MM;   q)\tREF 1-10013-309, SIZE 3-LEFT MED, 9MM;   r)\tREF 1-10013-310, SIZE 3-LEFT MED, 10MM;   s)\tREF 1-10013-311, SIZE 3-LEFT MED, 11MM;   t)\tREF 1-10013-313, SIZE 3-LEFT MED, 13MM;   u)\tREF 1-10013-359, SIZE 3-RIGHT MED, 9MM;   v)\tREF 1-10013-360, SIZE 3-RIGHT MED, 10MM;   w)\tREF 1-10013-361, SIZE 3-RIGHT MED, 11MM;   x)\tREF 1-10013-363, SIZE 3-RIGHT MED, 13MM;   y)\tREF 1-10013-409, SIZE 4-LEFT MED, 9MM;   z)\tREF 1-10013-410, SIZE 4-LEFT MED, 10MM;   aa)\tREF 1-10013-411, SIZE 4-LEFT MED, 11MM;   bb) REF 1-10013-413, SIZE 4-LEFT MED, 13MM;   cc)\tREF 1-10013-459, SIZE 4-RIGHT MED, 9MM;   dd) REF 1-10013-460, SIZE 4-RIGHT MED, 10MM;   ee)\tREF 1-10013-461, SIZE 4-RIGHT MED, 11MM;   ff)\tREF 1-10013-463, SIZE 4-RIGHT MED, 13MM;   gg)\tREF 1-10013-509, SIZE 5-LEFT MED, 9MM;   hh) REF 1-10013-510, SIZE 5-LEFT MED, 10MM;   ii)\tREF 1-10013-511, SIZE 5-LEFT MED, 11MM;   jj)\tREF 1-10013-513, SIZE 5-LEFT MED, 13MM;   kk)\tREF 1-10013-559, SIZE 5-RIGHT MED, 9MM;   ll)\tREF 1-10013-560, SIZE 5-RIGHT MED, 10MM;   mm) REF 1-10013-561, SIZE 5-RIGHT MED, 11MM;   nn) REF 1-10013-563, SIZE 5-RIGHT MED, 13MM;   oo) REF 1-10013-609, SIZE 6-LEFT MED, 9MM;   pp) REF 1-10013-610, SIZE 6-LEFT MED, 10MM;   qq) REF 1-10013-611, SIZE 6-LEFT MED, 11MM;   rr)\tREF 1-10013-613, SIZE 6-LEFT MED, 13MM;   ss)\tREF 1-10013-659, SIZE 6-RIGHT MED, 9MM;   tt)\tREF 1-10013-660, SIZE 6-RIGHT MED, 10MM;   uu) REF 1-10013-661, SIZE 6-RIGHT MED, 11MM;   vv)\tREF 1-10013-663, SIZE 6-RIGHT MED, 13MM;   Unicondylar knee prothesis",
      "product_quantity": "7531 units",
      "reason_for_recall": "Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.",
      "recall_initiation_date": "20230502",
      "center_classification_date": "20230531",
      "report_date": "20230607",
      "code_info": "a) REF 1-10013-109, UDI/DI 885556873236;  b) REF 1-10013-110, UDI/DI 885556873243;  c) REF 1-10013-111, UDI/DI 885556873250;  d) REF 1-10013-113, UDI/DI 885556873267;  e) REF 1-10013-159, UDI/DI 885556873274;  f) REF 1-10013-160, UDI/DI 885556873281;  g) REF 1-10013-161, UDI/DI 885556873298;  h) REF 1-10013-163, UDI/DI 885556873304;  i) REF 1-10013-209, UDI/DI 885556873311;  j) REF 1-10013-210, UDI/DI 885556873328;  k) REF 1-10013-211, UDI/DI 885556873335;  l) REF 1-10013-213, UDI/DI 885556873342;  m) REF 1-10013-259, UDI/DI 885556873359;  n) REF 1-10013-260, UDI/DI 885556873366;  o) REF 1-10013-261, UDI/DI 885556873373;  p) REF 1-10013-263, UDI/DI 885556873380;  q) REF 1-10013-309, UDI/DI 885556873397;  r) REF 1-10013-310, UDI/DI 885556873403;  s) REF 1-10013-311, UDI/DI 885556873410;  t) REF 1-10013-313, UDI/DI 885556873427;  u) REF 1-10013-359, UDI/DI 885556873434;  v) REF 1-10013-360, UDI/DI 885556873441;  w) REF 1-10013-361, UDI/DI 885556873458;  x) REF 1-10013-363, UDI/DI 885556873465;  y) REF 1-10013-409, UDI/DI 885556873472;  z) REF 1-10013-410, UDI/DI 885556873489;  aa) REF 1-10013-411, UDI/DI 885556873502;  bb) REF 1-10013-413, UDI/DI 885556873519;  cc) REF 1-10013-459, UDI/DI 885556873526;  dd) REF 1-10013-460, UDI/DI 885556873564;  ee) REF 1-10013-461, UDI/DI 885556873601;  ff) REF 1-10013-463, UDI/DI 885556873649;  gg) REF 1-10013-509, UDI/DI 885556873670;  hh) REF 1-10013-510, UDI/DI 885556873717;  ii) REF 1-10013-511, UDI/DI 885556873762;  jj) REF 1-10013-513, UDI/DI 885556873816;  kk) REF 1-10013-559, UDI/DI 885556873854;  ll) REF 1-10013-560, UDI/DI 885556873892;  mm) REF 1-10013-561, UDI/DI 885556873939;  nn) REF 1-10013-563, UDI/DI 885556873984;  oo) REF 1-10013-609, UDI/DI 885556874028;  pp) REF 1-10013-610, UDI/DI 885556874059;  qq) REF 1-10013-611, UDI/DI 885556874097;  rr) REF 1-10013-613, UDI/DI 885556874134;  ss) REF 1-10013-659, UDI/DI 885556874196;  tt) REF 1-10013-660, UDI/DI 885556874233;  uu) REF 1-10013-661, UDI/DI 885556874288;  vv) REF 1-10013-663, UDI/DI 885556874318; ALL BATCHES"
    }
  ]
}