{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Bloomington",
      "address_1": "10801 Nesbitt Ave S",
      "reason_for_recall": "Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored.  This may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected.",
      "address_2": "",
      "product_quantity": "32253 units",
      "code_info": "All lots",
      "center_classification_date": "20180413",
      "distribution_pattern": "US Nationwide Distribution.",
      "state": "MN",
      "product_description": "Fornier Phantom Fiber(TM) Sutures:  Item Number\tDescription  SMB000425\t4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES  SMB000525\t5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES  SMP000425\t4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES  SMP000525\t5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES  SMSB0110\t1PK PHANTOM FIBER SZ 2 WHITE  SMSB0110N   \tlPK BIOFIBER SUTURE SZ 2 WHT NEEDLED  SMSB0112\t10 PK PHANTOM FIBER SZ 2 WHITE  SMSB0112N  \t10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED  SMSB0120\t1PK PHANTOM FIBER SZ 2 VIOLET  SMSB0120N\tlPK BIOFIBER SUTURE SZ 2 VLT NEEDLED  SMSB0122\t10 PK PHANTOM FIBER SZ 2 VIOLET  SMSB0122N\t10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED  SMSB0130\t1PK PHANTOM FIBER SZ 2 WHITE/VIOLET  SMSB0132\t10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET    Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.",
      "report_date": "20180425",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Tornier, Inc",
      "recall_number": "Z-1374-2018",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "79373",
      "termination_date": "20200807",
      "more_code_info": "",
      "recall_initiation_date": "20180208",
      "postal_code": "55437-3109",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}