{
  "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": "49970",
      "product_res_number": "Z-0396-2007",
      "event_date_initiated": "2006-12-20",
      "event_date_posted": "2007-02-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-07-12",
      "res_event_number": "37139",
      "product_code": "MQU",
      "k_numbers": [
        "K974203"
      ],
      "product_description": "Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045      \n\nThe threaded sleeve and flat peg are two components of the P-K Titanium Motility/Support System. The threaded sleeve is an externally threaded cylinder and an internal drilled hole designed to receive a peg. It is placed in the Bioeye Hydroxyapatite Implant with the use of the P-K Titanium threaded sleeve wrench after a hole has been prepared in the implant by drilling with a series of hypodermic needles of gradually increasing sizes. After the threaded sleeve is placed in the implant, any of the P-K Pegs can be inserted.\n\nThe affected model which is the subject of this recall comes with the flat peg.",
      "code_info": "Lot number: M-50021 Product is not serialized.  Note: Lot code assigned by the contract manufacturing firm.",
      "firm_fei_number": "3009688114",
      "recalling_firm": "Integrated Orbital Implants Inc",
      "address_1": "12625 High Bluff Dr Ste 314 12625 High Bluff Dr",
      "address_2": "Ste 314",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92130-2054",
      "additional_info_contact": "Natalie J. Kennel\n858-259-4355",
      "reason_for_recall": "The threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion.  Failure to properly identify the affected components and apply the modified insertion technique will result in an inability to insert the sleeve into the implant.",
      "root_cause_description": "Other",
      "action": "All domestic customers were notified by phone call on 12//20/2006 which was followed up with a fax and the letter sent registered mail.  Internationally, customers were notified by fax, email and mail.\n\nCustomers were instructed to check their inventory of the product by lot number and visual inspection. They were instructed to isolate the affected inventory. They were provided with alternate instructions on how to use the product as it is, if needed. They were provided with a reply card to complete and fax back to the company. They were instructed that when replacement product becomes available, they will be contacted to arrange for the exchange of the affected product.",
      "product_quantity": "234",
      "distribution_pattern": "Worldwide, including USA, United Arab Emirates, Canada, Mexico, Costa Rica, Taiwan & Romania.",
      "openfda": {
        "k_number": [
          "K980822",
          "K971583",
          "K974203",
          "K000151"
        ],
        "registration_number": [
          "2027377",
          "9615745",
          "3004467263",
          "3002991496",
          "8010177"
        ],
        "fei_number": [
          "3004467263",
          "3000314405",
          "3002991496",
          "3002821504",
          "3009688114"
        ],
        "device_name": "Ocular Peg",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.3320",
        "device_class": "2"
      }
    }
  ]
}