{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "91084", "product_res_number": "Z-0143-2012", "event_date_initiated": "2010-03-31", "event_date_posted": "2011-11-01", "recall_status": "Terminated", "event_date_terminated": "2012-04-04", "res_event_number": "55537", "product_code": "JEY", "k_numbers": [ "K082757" ], "product_description": "Bioplate Titanium Fixation System, Sterile Kit.\n\nThe sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant.", "code_info": "Product Code\tLot # 81-2093\t\tG03411108  G03680409  81-2094\t\tG03421108  G03690409  81-3573\t\t1000  1002   1527  G03251108  G03630409  G03920709  81-3574\t\tG03391108  G03650409  81-3575\t\t1004  1543  G03261108  G03431208  G03660409  G03740509  G03880709  81-3576\t\t1244  1561  G03221108  G03670409  81-3577\t\tG03231108  G03640409  G03820609  G03890709  81-3578\t\t1075  1690  G03241108  G03830609   81-3579\t\t1167  1562  G03401108  G03450109  81-3580\t\t185  G03211108  G03460109  G03590309  G03840609  81-3581\t\t414  1034  1524  1894  G03201108  G03600309  G03750509  G03870609  G03900709  81-3582 993  1220  1692  G03331108  G03770509  G03910709  81-3583\t\tG03271108 \t\tG03790509  81-3584\t\tG03341108  G03850609  81-3585\t\tG03351108  G03610309  81-3586\t\t1005  G03371108  81-3587\t\tG03361108  81-3588\t\t1812  G03381108  G03860609  81-3590\t\tG03311108  G03440109  G03550209  81-3591\t\t1637  1816  G03321108  G03480109  G03560209  G03620309  81-3592\t\t1069  G03490109  G03570209  G03780509  81-3593\t\t1070  G03470109  81-5888\t\t1813  81-5890\t\t1043  81-5894\t\tG03281108  81-5895\t\t1023  1227  1240  1817  G03291108  81-5896\t\tG03301108   81-5900\t\t1814  G03700409  81-5901\t\tG03710409  81-5902\t\tG03720409  81-5903\t\t1818  G03730409  G03760509", "firm_fei_number": "1000518793", "recalling_firm": "Bioplate Inc", "address_1": "3643 Lenawee Ave", "city": "Los Angeles", "state": "CA", "postal_code": "90016-4310", "additional_info_contact": "Chelsea Mitchell\n310-815-2126", "reason_for_recall": "There is potential defect in seal of the sterile barrier containing the device.", "root_cause_description": "Process design", "action": "BIOPLATE sent an URGENT - PRODUCT RECALL NOTIFICATION letter dated March 18, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.\n\nCustomers were instructed to return any recalled product they have at their site\nand if distributed further they should forward the information contained in the letter to all customers.\n \nIf a device from one of the lots noted above has already been used, Bioplate would like to be advised of that use.\n\nThey asked that consignees complete the enclosed Fax form and transmit the requested information to them as soon as possible at (310) 815-2126.\n\nReturned recalled product was to be sent to: \n\nBioplate\n3643 Lenawee Avenue\nLos Angeles, CA 90016\n3643 Lenawee Avenue, Los Angeles, CA 90016\n\nFor any questions regarding this recall call (310) 815-2100.", "product_quantity": "16,020 Individual Kits; 2,226 Boxes.", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and the countries of Canada, Europe, Japan, Taiwan, Middle East and Australia.", "openfda": { "k_number": [ 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"3006017180", "3015869121", "3002807310", "3002806429", "3011302692" ], "device_name": "Plate, Bone", "medical_specialty_description": "Dental", "regulation_number": "872.4760", "device_class": "2" } } ] }