{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "124869", "product_res_number": "Z-0830-2014", "event_date_initiated": "2011-03-31", "event_date_posted": "2014-01-27", "recall_status": "Terminated", "event_date_terminated": "2019-07-18", "res_event_number": "67176", "product_code": "GFF", "k_numbers": [ "K011444", "K974025" ], "product_description": "Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only\n\nSingle use Sterile bone cutting burs.", "code_info": "Lot #'s: D323038131 and D343038845", "firm_fei_number": "1045834", "recalling_firm": "The Anspach Effort, Inc.", "address_1": "4500 Riverside Drive", "city": "Palm Beach Gardens", "state": "FL", "postal_code": "33410-4235", "additional_info_contact": "Customer Service\n800-327-6887", "reason_for_recall": "Cutter was longer than was stated on the label", "root_cause_description": "Pending", "action": "Anspach sent an Urgent Medical Device Product Removal letter dated March, 32, 2013, to all affeced customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inventory their batches and return the products for replacement. Customers needing assistance were instructed to contact Anspach at 800-327-6887.\nFor questions regarding this recall, call 800-327-6887.", "product_quantity": "29 cutting burs", "distribution_pattern": "Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.", "openfda": { "k_number": [ "K943758", "K974025", "K883255", "K820281", "K934583", "K821485", "K880706", "K880859", "K862852", "K853658", "K850497", "K872475", "K950449", "K841298", "K890090", "K894438" ], "registration_number": [ "3004519921", "3011371465", "3011230048", "8044057", "9681479", "3038191237", "3018094310", "3010536692", "1828288", "1017294", "3003755939", "3032747418", "8010516", "3016727307", "2134285", "3012329552", "3015882686", "3020704423", "3021393544", "2032830", "3021632375", "8010298", "3006554788", "3011354099", "3008936260", "3008812560", "2133928", "1051526", "2183570", "1526534", "3010400367", "8030607", "2020356", 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