{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Orange",
      "address_1": "1717 W Collins Ave",
      "reason_for_recall": "Kerr Corporation is initiating this recall because raw material used  to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly.",
      "address_2": "",
      "product_quantity": "40,819 kit and syringe units",
      "code_info": "34417 KIT- MAXCEM ELITE INTRO 2-4662052  4672087  4694484  4698107  4710901  4719936  4725775  4725776  34418 KIT - MAXCEM ELITE BULK-4706738  4656479  4656480  4666810  4666811  4666813  4668612  4709788  4710900  4712887  4725780  4729919  4734053  4744195  SYRINGE LOT NUMBERS  34417 & 34418 SYRINGE- MAXCEM ELITE CLEAR  Individually affected syringes within Kits listed above-4663716  4663717  4690551  4690552  4704821  4728088  4741721  33872 REFILL- MAXCEM ELITE CLEAR-4664825  4669840  4669841  4672089  4676812  4676815  4678974  4678975  4690548  4690549  4690550  4702597  4710904  4710905  4718097  4720553  4720555  4720558  4720560  4720562  4720563  4720564  4720565  33873 REFILL- MAXCEM ELITE WHITE-4681749  4699954  4704804  4720556  4720567  4720568  4720569  4720573  4720574  4720575  33874 -REFILL- MAXCEM ELITE WHITE OPAQUE-4720576  4720577  4720578  4720579  4720580  33875-REFILL- MAXCEM ELITE YELLOW -4652147  4696832  4720198  33876 -REFILL- MAXCEM ELITE BROWN -4710907  4725879  34055 MAXCEM ELITE STANDARD KIT-4620128  4656894  4680372  4709328  4728932  4732387  4733719  4735545  4748933  4759314  34056 -MAXCEM ELITE VALUE KIT-4719214  4759315  4698814  34057 -MAXCEM ELITE MINI KIT-4709329  4714775  4728934  4732388  4756503  34058 MAXCEM ELITE REFILL CLEAR-4628189  4728840  4728844  4728935  4730842  4732144  4735257  4735546  4748934  4756504  34059 -MAXCEM ELITE REFILL WHITE-4705713  4728936  4745082  4756505  34060 MAXCEM ELITE REFILL WHITE OPAQUE-4719215  4735547  4768408  34061 MAXCEM ELITE REFILL YELLOW -4700948  4705714  4728937  4756506  4768409  34062 MAXCEM ELITE REFILL BROWN -4709330  4738886  4749728  MAXCEM ELITE CLEAR FILLED SYRINGE-4679149  4679150  4681816  4681817  4685882  4685882  4694026  4694026  4694028  4694030  4708393  4708393  4717716  4721155  4733694  4741330  4756672  4756673  4766817  MAXCEM ELITE WHITE OPAQUE FILLED SYRINGE -4684879  4685879  4733678  MAXCEM ELITE YELLOW FILLED SYRINGE -4689433  4689433  4693134  4693134  4717719  4743042  4770898  MAXCEM ELITE BROWN FILLED SYRINGE -4708392",
      "center_classification_date": "20130409",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, Belgium, Czech Republic, France, Great Britain, Poland, Albania, Austria, Bulgaria, Switzerland, Cyprus, Germany, Denmark, Estonia, Spain, Finland, Croatia, Hungary, Ireland, ITtaly Luxembourg, Latvia, Netherlands, Norway, Portugal, Romania, Serbia (Republic of Serbia), Sweden, Slovenia, Turkey, Ukraine, United Arab Emirates, Congo, The Democratic Republic of the (formerly Zaire), Kazakhstan, Lebanon, Russian Federation, South Africa, Mexico, Thailand, Brazil, China, Hong Kong, Israel, India, Japan, Malaysia, Panama, Singapore, Viet Nam.",
      "state": "CA",
      "product_description": "Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0.    Used for cementation of all indirect restorations.",
      "report_date": "20130417",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical",
      "recall_number": "Z-1076-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "64559",
      "termination_date": "20140122",
      "more_code_info": "",
      "recall_initiation_date": "20130222",
      "postal_code": "92867-5422",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}