{ "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": "76778", "product_res_number": "Z-0906-2009", "event_date_initiated": "2008-05-21", "event_date_created": "2015-06-25", "recall_status": "Terminated", "event_date_terminated": "2009-09-11", "res_event_number": "50737", "product_code": "EMG", "product_description": "Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8\", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original OBWEGESER Instruments. Walter Lorenz Surgical, Inc., Subsidiary of Biomet Microfixation, Inc. NOTE: None distributed domestically. \n\nCranio-maxillofacial manual instrumentation to be used to aid in the treatment and care of patients, as determined appropriate, by a trained medical professional. The Obwegeser Ramus Clamps are self-retaining clamps, used on the ascending ramus of the mandible with an extension on one of the blades (shields) to aid in retracting the soft tissue of the cheek.", "code_info": "Lot Number 050801.", "firm_fei_number": "1032347", "recalling_firm": "Biomet Microfixation, Inc.", "address_1": "1520 Tradeport Dr", "city": "Jacksonville", "state": "FL", "postal_code": "32218-2480", "additional_info_contact": "904-741-4400", "reason_for_recall": "The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly etched as the left part number 01-7997.", "root_cause_description": "Labeling mix-ups", "action": "Customers were contacted by e-mail notification with read receipt. Customers were notified in the e-mail to immediately discontinue use of the recalled product and return the affected items to Biomet Microfixation, Inc. The e-mail also included an Inventory Reconciliation form for customers to complete and return via fax (904-741-1801) to Biomet Microfixation, Inc. For questions related to this notice, please call 1-800-874-7711 or 904-741-4400 extension 448, Monday through Friday, 8 a.m.-4 p.m. Eastern Standard Time (EST).", "product_quantity": "4", "distribution_pattern": "International Distribution including countries of Ireland and Japan.", "openfda": { "device_name": "Forceps, Tooth Extractor, Surgical", "medical_specialty_description": "Dental", "regulation_number": "872.4565", "device_class": "1", "k_number": [ "K840312", "K060691", "K821781", "K823325", "K062130", "K851709", "K851712", "K851105", "K851708", "K851711" ], "registration_number": [ "", "8041151", "3012226300", "5906", "3005528784", "3014683120", "3005067367", "3010288346", "3013496867", "3045811395", "3022862651", "1417592", "3007773213", "3003418325", "9616250", "3001408183", "8010516", "3013463240", "9610612", "8040179", "3008711893", "9680515", "2531684", "3029082594", "9613083", "3030644259", "8040233", "1720747", "8010732", "3038191347", "3021666757", "3008346537", 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