{
  "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": "West Chester",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70580",
      "recalling_firm": "Synthes, Inc.",
      "address_1": "1302 Wrights Ln E",
      "address_2": "N/A",
      "postal_code": "19380-3417",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution",
      "recall_number": "Z-1260-2015",
      "product_description": "Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount.  This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients.    This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones.  In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.",
      "product_quantity": "1550",
      "reason_for_recall": "The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter for the TEN in the form of the chuck getting stuck/jammed, breakage of the cross bar of the Inserter for the TEN.",
      "recall_initiation_date": "20150203",
      "center_classification_date": "20150310",
      "termination_date": "20160826",
      "report_date": "20150318",
      "code_info": "Part Number: 359.219,   Sold As Lot Numbers: 4321659 4340451 4466686 4470900 5496455 5700078  5718485 5718486 5718487 1904339 3005674 3005675 3009312 3020674 3025607 3051190 3054608 3065013 3069566 3084637 3098634 3121438  3232931 3242304 3262712 3301017 3325276 3382583 3410330 3430483  3493588 3504996 3524633 3619119 3626055 3659645 3706611 3797835  7505411 7565990 7601112 7619995 7670741 7675623 7727696 7774491  7810649 7845943 7874224 7896075  7979727 4796463 4826021 4911859  4911860 4969014 4971314 5066417 5042001 5066418  5090226 5090224  5106335 5123586 5162204 5123587 5162205 5162206 5162760 5181760  5181761 5227459 5236654 5258103 5420946 5422955 5455364 5455365  5507788 5525235 5485078 5492810 5545372 5555604 5569028 5611445  5611446 5611447 5641430 5670475 5641429 5657075 5657073 5670474  5700077 5700079 8114862 8214803 8326267 8424513 8476286 8541845  8608192 8608193 8768253 8973607 9275702 4389269 4537554 4594280  4594281 4825384;    (Manufacturing Lot Numbers:  1095607  1095607  1121876  1121876  1641700  1806500  1811056  1811059  1813900  1904339  3005674  3005675  3009312  3020674  3025607  3051190  3054608  3065013  3069566  3084637  3098634  3121438  3232931  3242304  3262712  3301017  3325276  3382583  3410330  3430483  3493588  3504996  3524633  3619119  3626055  3659645  3706611  3797835  7505411  7565990  7601112  7619995  7670741  7675623  7727696  7774491  7810649  7845943  7874224  7896075  7979727  8000136  8002518  8002635  8002635  8004538  8004538  8005179  8006103  8006214  8006214  8006578  8006578  8007139  8007139  8007472  8007472  8008046  8008046  8008046  8008261  8009205  8009363  8009859  8012109  8012353  8012925  8013244  8014078  8014078  8014645  8014645  8015605  8015831  8016063  8016128  8016128  8016128  8016423  8016423  8016759  8017447  8017590  8017862  8017872  8018319  8114862  8214803  8326267  8424513  8476286  8541845  8608192  8608193  8768253  8973607  9275702  A8LA901  A8MA648  A8MB744  A8NA025  A8NA430)"
    }
  ]
}