{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216370",
      "product_res_number": "Z-0488-2026",
      "event_date_initiated": "2025-10-13",
      "event_date_posted": "2025-11-14",
      "recall_status": "Open, Classified",
      "res_event_number": "97703",
      "product_code": "LZD",
      "pma_numbers": [
        "P980052"
      ],
      "product_description": "TMJ Bilateral Implant\nREF: CHG020\nSterile EO, Rx Only",
      "code_info": "UDI: 07613327626551,07613327626568,07613327626575,07613327626605,07613327627749\n07613327627848/ Lot #s: 2410301062\t2306091054\t2312121078\t2401181023\t2401231058\t2403191046\t2404291064\t2405021079\t2407221023\t2407241032\t2408081047\t2408131037\t2408161043\t2409031033\t2409241016\t2410011097\t2410071065\t2410091014\t2410111030\t2410291062\t2411111012\t2411121044\t2411201015\t2412061031\t2412121062\t2412201009\t2501021011",
      "firm_fei_number": "3001237463",
      "recalling_firm": "TMJ Solutions Inc",
      "address_1": "6059 King Dr",
      "city": "Ventura",
      "state": "CA",
      "postal_code": "93003-7607",
      "additional_info_contact": "Quality Department \n805-650-3391",
      "reason_for_recall": "Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.",
      "root_cause_description": "Process control",
      "action": "On February 25, 2026 Stryker (TMJ Solutions) issued a \" Urgent: Medical Device Recall\" Expansion notification to additional, affected consignees. Initial notification and previous expansion was issued on  September 30, 2025 and December 4, 2025. TMJ Solutions asked consignees to take the following actions:   \n\n1. Inform individuals within your organization who need to be aware of this action.\n2. Check your internal inventory to locate the affected product (Attachment B). Segregate the affected products, quarantine and discontinue use.\n3. Please complete the Business Reply Form or use the QR Code on Attachment A. Response is required.\n\na. If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt.\n\n4. Maintain awareness of this communication internally until all required actions have been completed within your\nfacility .",
      "product_quantity": "63 units",
      "distribution_pattern": "US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN,  GA\nOUS: Canada, Spain, Brazil,",
      "openfda": {
        "pma_number": [
          "P020016",
          "P980052",
          "P000023"
        ],
        "registration_number": [
          "1032347",
          "2031049",
          "1450662",
          "1828288",
          "1064858",
          "3010927122",
          "1529009",
          "8010177"
        ],
        "fei_number": [
          "1000149660",
          "1032347",
          "1450662",
          "3008397795",
          "3002821504",
          "1828288",
          "3001237463",
          "3010927122"
        ],
        "device_name": "Joint, Temporomandibular, Implant",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.3940",
        "device_class": "3"
      }
    }
  ]
}