{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "188615", "product_res_number": "Z-2336-2021", "event_date_initiated": "2021-06-25", "event_date_created": "2021-08-24", "recall_status": "Open, Classified", "res_event_number": "88427", "product_code": "MQC", "k_numbers": [ "K183598" ], "product_description": "KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.\n\nModel (Ref) #: 4220005", "code_info": "Lot Number: KJ2858\nShelf Life (Expiration Date): 22 April 2023\nUnique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U", "firm_fei_number": "1000121052", "recalling_firm": "Straumann USA LLC", "address_1": "60 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1008", "additional_info_contact": "SAME\n978-747-2560", "reason_for_recall": "Product label intended for the European community was distributed to the USA market via their US distribution organization", "root_cause_description": "Process control", "action": "Straumann USA initial notification to the customer via phone call on 25 June 2021. A follow-up letter dated 7/2/21 issued. Letter states reason for recall, health risk and action to take:\nAction to be taken:\n1.\tBased on our conversation on 25 June 2021, you did not use and you have segregated the product and it was made ready to ship back to us.\n2.\tComplete and return the enclosed Customer Confirmation Form to FSCA ER21-0118, Straumann USA, LLC; 60 Minuteman Road, Andover, MA 01810 along with the product using the attached label.", "distribution_pattern": "US Nationwide distribution in the state of TX.", "openfda": { "k_number": [ "K210011", "K231793", "K241311", "K071404", "K170985", "K232087", "K190107", "K232448", "K243516", "K222061", "K251252", "K202465", "K214102", "K110468", "K231775", "K250743", "K111066", "K090472", "K102909", "K981546", "K191836", "K111828", "K143655", "K230548", "K134015", "K151933", "K212767", "K211415", "K223798", "K230592", "K203000", "K014079", "K201091", "K091880", "K061122", "K241369", "K123161", "K022627", "K201173", "K030832", "K181361", "K212017", "K082723", "K072522", "K222845", "K240463", "K221022", "K220894", "K230495", "K024261", "K053580", "K062828", "K980953", "K210940", "K161884", "K040315", "K143623", "K182820", "K200125", "K183598", "K212448", "K230237", "K955701", "K063483", "K241729", "K203596", "K112868", "K253798", "K222604", "K022809", "K121365" ], "registration_number": [ "3030686055", "8044058", "3024749697", "2081322", "3005730680", "1043617", "3017520337", "9680954", "2086043", "3009432160", "8010662", "3020749939", "3013652641", "3008320092", "3003283852", "3039359767", "3010767848", "3015547648", "3013551048", "3011649314", "3012623144", "1723435", "3011532731", "3015491441", "3005343849", "3010279788", "3014888923", "3018783197", "3014270094", "3020093493", "3005598536", "3030515618", "2433919", "2523320", "3008347275", "2916735", "3022315836", "1719513", "3005942449", "3002789526", "2032273", "3021024355", "3022068322", "9614977", "3005904906", "3009727738", "8010908", "3025434480", "3013343038", "3001295407", "3021381014", "3009133124", "3012389497", "1415367", "3017575849", "1036212", "3011429437", "3005940400", "3004935484", "3027494823", "3010002722", "1483306", "2032807", "3015674635", "3030268763", "3009779268", "3004884150", "3004491043", "3006523393", "1316408", "3004086252", "2515379", "3017567754", "3009482106", "3016237718", "3009440973", "8030452", "3003794907", "3043044356", "3005350578", "3014289665", "3001389926", "3009815428", "2280629" ], "fei_number": [ "3030686055", "3024749697", "2081322", "3005730680", "1043617", "3017520337", "3002718942", "3009432160", "3020749939", "3003240904", "3013652641", "3003704180", "3008320092", "3003283852", "3039359767", "3010767848", "3015547648", "3013551048", "3011649314", "3012623144", "3011532731", "3000719964", "3015491441", "3005343849", "3010279788", "3014888923", "3018783197", "3014270094", "3003719498", "3020093493", "3005598536", "3030515618", "2433919", "2523320", "3008347275", "2916735", "3022315836", "1719513", "3005942449", "3003943714", "3002789526", "3000203342", "1000293792", "3021024355", "3022068322", "3005904906", "3009727738", "3025434480", "3013343038", "3001295407", "1000121639", "3021381014", "3009133124", "3012389497", "1415367", "3017575849", "1036212", "1000185289", "3011429437", "3005940400", "3004935484", "3027494823", "3010002722", "1483306", "3015674635", "3030268763", "3009779268", "3004884150", "3004491043", "3006523393", "1316408", "3004086252", "2515379", "3017567754", "3009482106", "3016237718", "3009440973", "3003794907", "3043044356", "3005350578", "3014289665", "3001389926", "5513", "3009815428" ], "device_name": "Mouthguard, Prescription", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "U" } } ] }