{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Austin",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96917",
      "recalling_firm": "Encore Medical, LP",
      "address_1": "9800 Metric Blvd",
      "address_2": "",
      "postal_code": "78758-5445",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "At time of quarantine:  RFK Medical Inc. Virginia (VA) CE102        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm      2       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm      1 Evolution Medical  North Dakota (ND), Minnesota (MN), Colorado (CO), Utah (UT) CE106        506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm      1       506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm      4 Valor Medical Solutions South Texas (TX) CE118        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm      6       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm      17 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX CE120        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm       1 Joint Ventures Medical LLC Wisconsin (WI) CE121        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        24       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm        1 WHISKEY TRAIL ORTHOPEDICS LLC - AUS Tennessee (TN)  CE123        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        8       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm        4 McCants Medical, LLC Florida (FL) CE128        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        4       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm        2 Florida Direct - FSW Medical Florida (FL) FL001        506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm        16       506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        14       506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         6       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         72       506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm         27       506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm         65 Great Lakes Medical Illinois (IL) GL108        506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm         8       506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm         6       506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         2       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         14 Certus Medical LLC Indiana (IN) & Michigan (MI) GL112        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm         14       506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         17       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm          3       506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm         23 I & S Medical  West Virginia (WV) & Kentucky (KY)  GL113        506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         1       506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm         8 Osteo Solutions  Ohio (OH), Kentucky (KY),  GL114        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        15       506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm        16       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         6       506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm        32 Procore Medical, LLC North Carolina (NC)  MA102        506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm        1       506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        14       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm         2       506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm        59 Medsource Rhode Island (RI), Massachusetts (MA) NE131        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        3       506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm        12       506-04-126 5037A1017 ALTIVATE REVERSE TORX PER",
      "recall_number": "Z-2009-2025",
      "product_description": "Brand Name: ALTIVATE REVERSE  Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm  Model/Catalog Number: 506-04-122  Software Version: NA  Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.  Component: NA",
      "product_quantity": "200 units",
      "reason_for_recall": "Package labeling for Altivate Reverse Torx Peripheral screw contains a different size  then actual  included product.",
      "recall_initiation_date": "20250528",
      "center_classification_date": "20250623",
      "report_date": "20250702",
      "code_info": "Lot Code: Item: 506-04-122 GTIN: 00190446829843 Lot: 5035A1018",
      "more_code_info": ""
    }
  ]
}