{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "122603",
      "product_res_number": "Z-0353-2014",
      "event_date_initiated": "2013-10-13",
      "event_date_posted": "2013-11-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-12-10",
      "res_event_number": "66558",
      "product_code": "ONA",
      "k_numbers": [
        "K123548"
      ],
      "product_description": "Epsilon Skin Tensioner:Rx, Sterile\nSterilized using Gamma. Turns Red if sterilized using Gamma;\n\nProduct Usage:\nSkin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.",
      "code_info": "Model number FP-45384",
      "firm_fei_number": "3006515340",
      "recalling_firm": "Restoration Robotics",
      "address_1": "128 Bayview Drive",
      "city": "San Jose",
      "state": "CA",
      "postal_code": "95134",
      "additional_info_contact": "Jim Talbot\n408-883-6760",
      "reason_for_recall": "Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers.  Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has\nbeen identified as a compound of iron and chlorine.",
      "root_cause_description": "Process control",
      "action": "Restoration Robotics sent an Urgent Recall letters dated October 13, 2013 to all distributors via first class mail. Direct accounts were notified by phone as well as fax.  Customers were informed of the affected product, problem and actions to be taken.  Replacement products are being distributed to each site and will be delivered to each customer.  For questions call 408-883-6760",
      "product_quantity": "515 in US. 315 International.(included all packaging configurations)",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide in the countries of:  Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.",
      "openfda": {
        "k_number": [
          "K103428",
          "K173358",
          "K123548",
          "K123154"
        ],
        "registration_number": [
          "3006515340",
          "3013586954"
        ],
        "fei_number": [
          "3006515340",
          "3013586954"
        ],
        "device_name": "Computer Assisted Hair Harvesting System",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4560",
        "device_class": "2"
      }
    }
  ]
}