{ "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": 1 } }, "results": [ { "cfres_id": "168018", "product_res_number": "Z-0414-2019", "event_date_initiated": "2018-08-16", "event_date_posted": "2018-11-09", "recall_status": "Terminated", "event_date_terminated": "2020-06-23", "res_event_number": "81282", "product_code": "LYC", "k_numbers": [ "K062846" ], "product_description": "BioMend Extend, REF# 0142Z, Synthetic bone grafting material.", "code_info": "CDMEN18F1, CDMEN18F3", "firm_fei_number": "3003300673", "recalling_firm": "Collagen Matrix, Inc.", "address_1": "110 Commerce Dr", "city": "Allendale", "state": "NJ", "postal_code": "07401-1622", "additional_info_contact": "Customer Service\n800-342-5454", "reason_for_recall": "There is a possibility that the product was packaged in the wrong\nbox. Specifically, the product may have been placed inside a BioMend box instead of a\nBioMend Extend box. The only difference between the two boxes is the\nproduct trade name. The label placed on the box and on the product packaged inside the box is\ncorrect. The Instructions for Use inside the box are correct.", "root_cause_description": "Employee error", "action": "On August 16, 2018, Zimmer Biomet Dental issued Urgent Medical Device Recall Notices to affected customers. The letter described the issue and specified that there was no projected risk to patient health. \n\nCLINICIAN RESPONSIBILITIES:\n\nComplete the attached Certificate of Acknowledgement within 15 days of receipt and email the\ncompleted form to postmarket@zimmerbiomet.com or return the form to:\nProduct Recall\nZimmer Biomet\n4555 Riverside Dr.\nPalm Beach Gardens, FL 33410\n\nIf any of the items noted in the scope of this letter remain in your possession, please return\nthem along with a copy of the form to the address shown above. Replacement product will be\nprovided upon receipt of the return.\n\nIf you have any questions after reviewing this notice, please call 800-342-5454 between 8:00\nam and 5:00 pm EST, Monday through Friday. Calls received outside of call center operating\nhours will receive a prompt to leave a voicemail.", "product_quantity": "569", "distribution_pattern": "Distributed to one distributor located in Florida.", "openfda": { "k_number": [ "K962786", "K993784", "K924286", "K992416", "K093871", "K091484", "K110449", "K031813", "K073571", "K020396", "K962548", "K934947", "K023799", "K972817", "K083742", "K970569", "K063596", "K071817", "K860983", "K083372", "K852199", "K080772", "K955096", "K093390", "K053387", "K954763", "K082286", "K920508", "K081432", "K053022", "K880371", "K843153", "K950598", "K201051", "K121177", "K090950", "K253883", "K852765", "K111087", "K011032", "K843154", "K791416", "K101718", "K082383", "K952617", "K820023", "K932866", "K051443", "K013346", "K950567", "K060285", "K101426", "K003286", "K950511", "K060732", "K083858", "K192597", "K201546", "K070055", "K012144", "K983104", "K244006", "K101827", "K072057", "K924408", "K090850", "K943186", "K821752", "K253317", 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"K810382", "K112716", "K952619", "K052493", "K062834", "K950306", "K011403", "K031073", "K842163", "K241186", "K942946", "K981182", "K841201", "K972278", "K811101", "K910432", "K962624", "K003494", "K990537", "K964342", "K213260", "K063010", "K852766", "K020720", "K954631", "K850012", "K001598", "K973594", "K082917", "K092567", "K871773", "K062102", "K081561", "K960348", "K033098", "K003457", "K921468", "K010320", "K051381", "K923310", "K102872", "K000633", "K051885", "K830304", "K863176", "K921776", "K952922", "K063549", "K072056", "K974399", "K050260", "K842718", "K941780", "K993238", "K040783", "K051091", "K243745", "K970321", "K000149", "K902295", "K900136", "K153676", "K832509", "K863237", "K960361", "K131385", "K050984", "K003493", "K112428", "K922487", "K992216" ], "device_name": "Bone Grafting Material, Synthetic", "medical_specialty_description": "Dental", "regulation_number": "872.3930", "device_class": "2", "registration_number": [ "1220477", "9612827", "3013055499", 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