{
  "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": "Plantation",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73201",
      "recalling_firm": "Mako Surgical Corporation",
      "address_1": "2555 Davie Rd Ste 110",
      "address_2": "N/A",
      "postal_code": "33317-7424",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, LA, MI, MS, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, and WY ; and countries of: Italy, Scotland, Turkey, Greece, Germany, and Singapore.",
      "recall_number": "Z-1031-2016",
      "product_description": "Restoris Multicompartmental Knee (MCK) System    RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.",
      "product_quantity": "146",
      "reason_for_recall": "Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.",
      "recall_initiation_date": "20160115",
      "center_classification_date": "20160301",
      "termination_date": "20190806",
      "report_date": "20160309",
      "code_info": "Catalog # 180601 - Lot #'s: 26110111, 26300512-01, 26110112-01, and 26090311-01  Catalog # 180602 - Lot #'s: LET1484311012, 26020812-01, 26220512-01, 26180711-0126120211-01, 26301011-01, 26161111-01, and 26220512-02.  Catalog # 180603 - Lot #'s: LET 1388860512, 26010511-01, 26310811-01 and 26050112-01  Catalog # 180604 - Lot #'s: 26090512-01 and 26280412-01  Catalog # 180605 - Lot #'s: 26310512-01, 26270512-01, and 26250511-01  Catalog # 180606 - Lot #'s: LET1464570912, 26300412-01, 26140412-01, and 26050212-01.  Catalog # 180607 - Lot #'s: 26211011-01, 26040212-01, 26330512-01, 26090611-02, 26070811-01, LET1406460512, and 26230411-01.  Catalog # 180608 - Lot # 26141111-01  Catalog # 180611 - Lot #'s 26131111-01 and 26050211-01  Catalog # 180612 - Lot #'s 26190911-01, 36010112-1, 26070212-01, 26410611-01, 26020411-01, and 26060211-01  Catalog # 180613 Lot #'s 26271011-01 and 26240711-01  Catalog # 180614 - Lot #'s 36031211-1, 26180512-01, 26440611-01, and 26190612-01  Catalog # 180615 Lot # 2610012-01  Catalog # 180616 Lot #'s 26160212-01, 2634012-01, 26300811-01, 26171111-01, 26350512-01, and 26310612-01.  Catalog # 180617 Lot #'s 26310412-01, 26160711-01, 26210511-02, 26061011-01, 26061011-01, and LOT1388810512.  Catalog # 180618 Lot #'s: 26360512-01, 26060311-01, and 26061211-01."
    }
  ]
}