{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "103598", "product_res_number": "Z-0034-2012", "event_date_initiated": "2011-07-15", "event_date_posted": "2011-10-11", "recall_status": "Terminated", "event_date_terminated": "2013-03-01", "res_event_number": "59756", "product_code": "FZS", "k_numbers": [ "K101471" ], "product_description": "Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144\n\nThe Axle Torque Driver Handle is used to lock the set screw into the locking plate.", "code_info": "Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050", "firm_fei_number": "3005031160", "recalling_firm": "X Spine Systems Inc", "address_1": "452 Alexandersville Rd", "city": "Miamisburg", "state": "OH", "postal_code": "45342-3658", "additional_info_contact": "David M. Letteri\n937-847-8400 Ext. 115", "reason_for_recall": "The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque if the handles were turned at a very slow speed.", "root_cause_description": "Component design/selection", "action": "X-spine Systems, Inc. sent an URGENT DEVICE RECALL letter dated September 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their stock immediately to determine if they have any affected product. If so, customers were instructed once the set screw is tightened onto the locking plate, and resistance is detected in the handle, it will take less than 2 seconds to hear the handle \"click.\" The \"click\" indicates the torque limit was reached. If further resistance is felt after 2 seconds, the surgeon should release the handle from tension, and try again.\nIf the product was distributed further, they should contact their accounts, and advise them of this recall.\nThe firm will send replacement handles.\nFor any questions call (937) 847-8400, ext 115.", "product_quantity": "39 Torque Driver Handles", "distribution_pattern": "Nationwide Distribution including CA, CO, FL, IA, IN, LA, NY, PA, TN, TX and UT.", "openfda": { "registration_number": [ "", "8010298", "1054986", "3017980495", "2084346", "3004788213", "2245304", "3018094310", "3045853999", "3022862651", "3001084743", "3008004502", "3006487092", "9680026", "1722511", "3003775395", "3022320321", "3007185216", "9614986", "9611278", "3008911114", "9680889", "8010099", "3009822485", "1222188", "8010257", "3006142527", "3003694247", "9614062", "3012267976", "1057425", "9680059", "3038187464", "8010935", "3007589150", "3003431869", "2511556", "3015895045", "3023155873", 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