{
  "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": "Walnut Creek",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75630",
      "recalling_firm": "Thayer Intellectual Property, Inc.",
      "address_1": "1331 N California Blvd Ste 320",
      "address_2": "N/A",
      "postal_code": "94596-4563",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution in the states of CA, TX. MD, MI,VA, DC, UT, CT, ID,  SD, IN, and GA.",
      "recall_number": "Z-0702-2017",
      "product_description": "MANOS EX (CAT#TY-12-101)    Product Usage:  Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fasciitis who fail conservative therapy.",
      "product_quantity": "339 devices",
      "reason_for_recall": "The firm failed to notify current customers of IFU update/warning. During a recent FDA inspection, it was discovered that Thayer Intellectual Property, Inc. had revised their IFU to include a warning not to bend, deform or otherwise modify any part of the device. The warning was added as a result of a MAUDE report filed in December 2014 where a piece of the MANOS EX broke during use and was left in the patient's hand. The patient suffered a tendon injury and an additional surgery was required to remove the broken piece of the device and repair the tendon. FDA inspection found that while the firm had updated their IFU, they had not notified customers who had been shipped the device with the older version that did not include the warning. Risk: It is important for MANOS EX users to be aware that bending, deforming, or modifying the device could result in device breakage which could impact patient safety and device performance.",
      "recall_initiation_date": "20161104",
      "center_classification_date": "20161203",
      "termination_date": "20171213",
      "report_date": "20161214",
      "code_info": "LOT 1055337, Expiry 4/01/2015;  LOT 1071800. Expiry 5/1/2017;  LOT 1102580; Expiry 8/1/2017;  LOT 1154179; Expiry 12/01/2017."
    }
  ]
}