{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "204643", "product_res_number": "Z-0630-2024", "event_date_initiated": "2023-11-20", "event_date_posted": "2024-01-03", "recall_status": "Open, Classified", "res_event_number": "93522", "product_code": "MQC", "k_numbers": [ "K203000" ], "product_description": "KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental\nappliances such as mouthguards, nightguards, splints, repositioners, and retainers\nItem No.: 4220011", "code_info": "UDI: UDI +H66842200111/$$3251116NB3628L\nLot No. NB3628", "firm_fei_number": "3010002722", "recalling_firm": "Keystone Industries", "address_1": "480 S Democrat Rd", "city": "Gibbstown", "state": "NJ", "postal_code": "08027-1239", "additional_info_contact": "SAME\n856-663-4700", "reason_for_recall": "Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).", "root_cause_description": "Labeling mix-ups", "action": "Keystone Industries issued Urgent Medical Device Recall/Correction letter to Distributors \nbetween 10/20/2023 and 10/23/2023. Letter states reason for recall, health risk and action to take:\nFor immediate access, the correct IFU is available following this link: 4916111-NATLAB-1372-KeySplint_Hard_DOMESTIC_IFU_WEB.pdf (keystoneindustries.com)\nIMMEDIATE ACTIONS TO BE TAKEN\n1. Review product inventory and quarantine all affected product on hand. Open\nzip lock bag and remove the incorrect IFU. Place an X across the front panel\nof the IFU using a marker or pen. Take a picture of the IFU with an X then\ndiscard the IFUs. Record the information on the attached acknowledgement\nform.\n2. Keystone Industries will send you the correct IFUs for any items remaining in\nyour inventory upon receipt of the acknowledgement form.\n3. Review distribution records and identify all customers who were shipped the\naffected product lot.\n4. Send End User Notifications provided to you with this notification to all\nidentified customers that received product. Record evidence of notification on\nthe acknowledgement form.\nComplete the attached Acknowledgement of Medical Device Recall Form and\nreturn within 5 days of receiving this notice. Email the completed form to\namcclure@keystoneind.com\nIf you have any questions after reviewing this notice, please email using the\naddress below or call Caleb Barylski at 856-548-5205 between 8:00 am and 5:00\npm EST, Monday through Friday.", "product_quantity": "336 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the country of China.", "openfda": { "k_number": [ "K063483", "K230495", "K980953", "K241729", "K091880", "K061122", "K250743", "K111066", "K230237", "K201091", "K210011", "K022627", "K190107", "K123161", "K214102", "K201173", "K182820", "K241369", "K222845", "K203596", "K232448", "K183598", "K230548", "K203000", "K053580", "K232087", "K072522", "K161884", "K212767", "K212017", "K202465", "K022809", "K024261", "K241311", "K030832", "K251252", "K955701", "K191836", "K062828", "K222061", "K071404", "K143655", "K090472", "K212448", "K082723", "K230592", "K014079", "K240463", "K181361", "K170985", "K981546", "K040315", "K121365", "K231775", "K220894", "K222604", "K200125", "K211415", "K253798", "K243516", "K231793", "K223798", "K221022", "K143623", "K112868", "K111828", "K110468", "K151933", "K134015", "K210940", "K102909" ], "device_name": "Mouthguard, Prescription", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "U", "registration_number": [ "3012623144", "3001389926", "3014289665", "2916735", "2032807", "3030515618", "1723435", "3021024355", "2032273", "3013551048", "1043617", "3010002722", "8030452", "3005904906", "2280629", "3005730680", "2523320", "3005942449", "3009482106", "1415367", "3039359767", "3005343849", "3017567754", "3014888923", "3004884150", "2081322", "3030268763", "3030686055", "1483306", "3013652641", "3015547648", "3011649314", "3022315836", "3010279788", "8044058", "9680954", "3005598536", "3009432160", "3010767848", "3004491043", "3011532731", "3001295407", "3004935484", "3015674635", "3003794907", "3024749697", "2433919", "3005350578", "3009779268", "3016237718", "3006523393", "8010908", "3009815428", "3021381014", "3015491441", "3018783197", "3005940400", "3008347275", "3020749939", "3043044356", "3017575849", "3022068322", "3012389497", "2515379", "1719513", "9614977", "3004086252", "3011429437", "3014270094", "3013343038", "3009727738", "3002789526", "3009440973", "1316408", "3008320092", "1036212", "3025434480", "3009133124", "3027494823", "3020093493", "2086043", "8010662", "3017520337", "3003283852" ], "fei_number": [ "3012623144", "3001389926", "3014289665", "2916735", "3030515618", "3021024355", "3013551048", "5513", "1043617", "3010002722", "3005904906", "3005730680", "2523320", "3005942449", "3002718942", "3009482106", "1415367", "3039359767", "3005343849", "3017567754", "3014888923", "3004884150", "2081322", "3030268763", "3030686055", "3000203342", "1483306", "3013652641", "3015547648", "3011649314", "3003719498", "1000185289", "3022315836", "3010279788", "1000293792", "3005598536", "3009432160", "3000719964", "3010767848", "3004491043", "3011532731", "3001295407", "3004935484", "3015674635", "3003794907", "3024749697", "3003704180", "2433919", "3005350578", "3009779268", "3016237718", "3006523393", "3009815428", "3021381014", "3015491441", "3003943714", "3018783197", "3005940400", "3008347275", "3020749939", "3043044356", "3017575849", "3022068322", "3012389497", "2515379", "1719513", "3004086252", "3011429437", "3014270094", "3013343038", "3009727738", "3002789526", "3009440973", "1316408", "3008320092", "1036212", "3025434480", "3009133124", "3027494823", "1000121639", "3020093493", "3017520337", "3003283852", "3003240904" ] } } ] }