{ "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": "114201", "product_res_number": "Z-0401-2013", "event_date_initiated": "2012-10-25", "event_date_posted": "2012-11-20", "recall_status": "Terminated", "event_date_terminated": "2013-09-23", "res_event_number": "63557", "product_code": "LYC", "product_description": "BioPlant, a dental bone grafting material. BioPlant\nhas been assigned the product code LYC (Bone Grafting Material, Synthetic) by the\nFDA and is classified as a Class II Medical Device. \nBioPlant is a Class II Medical Device. The Device Listing Number is 0007254.\n\nBioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.", "code_info": "The BioPlant part numbers and lot numbers affected by this recall are as follows:  Product Description \t Part Numbers \tLot Numbers \t  BioPlant Curved Syringe, 0.125g \t216110 \tAll Production \t  BioPlant Curved Syringe, 0.25g \t216112 \t  BioPlant Curved Svrinoe, 0.50<1 \t216114 \tLots Within Shelf-Life\t  BioPlant Curved Svrinoe, 0.250 \t216132 20k\t  BioPlant Intro Pack \t\t216112S", "firm_fei_number": "2024312", "recalling_firm": "Kerr Corporation", "address_1": "1717 W Collins Ave", "city": "Orange", "state": "CA", "postal_code": "92867-5422", "additional_info_contact": "714-516-7400", "reason_for_recall": "The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.", "root_cause_description": "Labeling design", "action": "Kerr Corporation sent an Urgent Medical Device Correction letter and acknowledgement form dated October 25, 2012, to all affected customers via USPS First Class. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: \"...review the table with product description , part numbers and lot numbers to determine if they have any of the affected product in their inventory and confirm that they were aware of the additional placement instructions necessary to achieve desired ossification results detailed in the paragraph in the letter. Customers were instructed to contact Kerr Customer Care at 18005377123 if they have any questions. Customers were also instructed to complete and fax back the enclosed Acknowledgement Form to 714-288-4609 in order to confirm their receipt of this correction regardless of whether they have any affected product in their inventory.\nFor questions regarding this recall call 714-516-7400.", "product_quantity": "22,410 units", "distribution_pattern": "Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees\n.", "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", 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