{
  "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": [
    {
      "status": "Terminated",
      "city": "Bedford",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72108",
      "recalling_firm": "ConforMIS, Inc.",
      "address_1": "28 Crosby Dr",
      "address_2": "N/A",
      "postal_code": "01730-1402",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Distributed Nationwide and in Germany, Switzerland, and UK.",
      "recall_number": "Z-0147-2016",
      "product_description": "ConFormis iTotal Posterior Stabilized Knee Replacement System-   ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and   ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT  Catalog Number:TPS1111111",
      "product_quantity": "110 units",
      "reason_for_recall": "May contain small amounts of ethylene glycol residue",
      "recall_initiation_date": "20150831",
      "center_classification_date": "20151021",
      "termination_date": "20160302",
      "report_date": "20151028",
      "code_info": "Serial Numbers (US):  Left:  0353417  0353616  0354944  0353554  0348951  0354052  0351267  0352723  0353063  0353116  0352223  0351354  0353685  0354118  0354573  0351678  0354306  0355213  0354531  0352895  0353969  0354670  0352804  0353375  0353584  0353955  0353394  0354457  0354251  0354470  0353392  0351881  0353596  0352702  0354028  0354049  0352925  0354005  0354115  0354863  0352181  0354089  0353451  0354720  0352945  0353262  0353662  0353269    Right::  0353557  0354179  0350279  0355149  0353833  0353430  0353480  0353628  0354373  0352045  0353346  0350509  0352556  0353120  0353287  0353535  0354487  0354691  0351677  0354706  0353997  0354119  0353421  0353585  0353580  0353617  0354393  0354940  0353390  0353634  0353720  0354226  0353080  0353372  0353096  0354048  0354050  0354054  0354947  0353806  0354257  0354478  0354938  0355240  0354063  0352352  0353728  0353725  0354430  0353278  0353433  0353810  0352946  0353664  0353665  0354247    Serial Numbers:  (OUS)  iTOTAL PSIPOLYIMPLANT KIT LEFT 0352550  ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353042  ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353150  ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353250  ITOTAL PSIPOLYIMPLANT KIT LEFT 0353544"
    }
  ]
}