{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 14 } }, "results": [ { "cfres_id": "113454", "product_res_number": "Z-0268-2013", "event_date_initiated": "2012-02-21", "event_date_posted": "2012-11-08", "recall_status": "Terminated", "event_date_terminated": "2012-11-15", "res_event_number": "63297", "product_code": "ELW", "k_numbers": [ "K050604" ], "product_description": "The brand name of the device is AlgiNot, a dental impression material.\nProduct \t Part Numbers \t\t \nAlgiNot Intra Kit \t 34683 \t\t \nAlgiNot Volume Refills \t 34682 \t \n\n\nLot Number 1-1017\n\n\nAlgiNot is a Class II Medical Device. The device listing number this product is\n0136496 and the establishment registration number for Kerr Corporation is 1815757.\n\nIntended as an alternative to traditional alginate materials.", "code_info": "¿Product \t Part Numbers \tLot Number \t  AlgiNot Intra Kit \t 34683 \t1-1017 \t  AlgiNot Volume Refills \t 34682 \t1-1017", "firm_fei_number": "1815757", "recalling_firm": "Kerr Corporation", "address_1": "28200 Wick Rd", "city": "Romulus", "state": "MI", "postal_code": "48174-2639", "reason_for_recall": "The firm recalled the product because it may cure harder than expected within the\nshelf life, which could result in a material that may be more difficult to remove. Use of this product on\npatients with loose teeth may result in possible tooth fracture or tooth extraction.", "root_cause_description": "Nonconforming Material/Component", "action": "Kerr Corporation sent \"URGENT: MEDICAL DEVICE RECALL\" letters to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. US, Canadian, and Rest of World consignees were notified via USPS 1st class mail on June 19, 2012, and Australian\nconsignees on July 5, 2012. Consignees were instructed to complete and return the Acknowledgement Form. Notification of the recall expansion was sent, via USPS 1st class mail, on February 21, 2012 to US, Canadian, Australia and European, consignees; however, once further investigation determined that all unexpired lots of the product were affected, the Alginot recall was expanded a second recall letter was sent to clarify that all lots of AlgiNot FS Volume recall and AlgiNot recall expansion are affected by this expanded\nrecall. Letters were mailed to US, Canadian and Rest of World (ROW) customers on June 19, 2012; Australian and European consignees were notified of the expansion on July 5, 2012.\nAll consignees were instructed to complete the Return Form to acknowledge the updated instructions for use and the added cautionary statement. \nConsignees not responding are to be contacted at least three times via telephone/fax/e-mail as follow up on the recall.", "product_quantity": "45 kits and 87 refills", "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.", "openfda": { "k_number": [ "K132599", "K810839", "K113406", "K965083", "K242360", "K951075", "K013236", "K091267", "K082560", "K053014", "K053619", "K830044", "K141092", "K152180", "K884166", "K881091", "K050013", "K042878", "K910360", "K860532", "K233954", "K860146", "K894281", "K132869", "K935884", "K910165", "K151535", "K092867", "K810825", "K940120", "K081017", "K152861", "K963205", 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"K134008", "K955406", "K961201", "K110871", "K905032" ], "device_name": "Material, Impression", "medical_specialty_description": "Dental", "regulation_number": "872.3660", "device_class": "2", "registration_number": [ "3045891668", "2921595", "1450653", "8010908", "3012494290", "3007028587", "9614977", "3004425647", "3016447764", "9614794", "2087259", "3007743883", "2014676", "9610902", "3006694515", "3011203516", "2024949", "3025307990", "3008792854", "3005176727", "3032911850", "3002785217", "3042272797", "3003775534", "3027494823", "3010664129", "3023401336", "3035693034", "3045857207", "2024980", "9613953", "9612300", "3007353764", "3011187729", "3012187973", "2024312", "3010407924", "2081055", "3032435508", "3032312561", "3020749939", "3010131268", "9680954", "3032193293", "3015143007", "2437780", "3017575849", "3009496224", "3007046497", "3012354669", "9680845", "1530561", "3003103749", "3042244574", "3008912871", "3013012934", "3003120666", "3004158247", "3006316962", "2086043", 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