{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "131322", "product_res_number": "Z-0545-2015", "event_date_initiated": "2014-09-08", "event_date_posted": "2014-12-16", "recall_status": "Terminated", "event_date_terminated": "2017-11-29", "res_event_number": "69471", "product_code": "HBG", "product_description": "McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names.", "code_info": "1) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: McKenzie Perforator Drill, 13 mm; Phoenix Instruments Item Number: 157-6043; Lot Number: 070412.   2) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Stealth Surgical; Stealth Surgical Product Name: McKenzie Perforator Drill, 13 mm; Stealth Surgical Item Number: SS2151; Lot Number: 070412.   3) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: CareFusion; CareFusion Product Name: McKenzie Perforator Drill, 13 mm; CareFusion Item Number: VM85-1235; Lot Number: 030211.   4) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: CareFusion; CareFusion Product Name: McKenzie Perforator Drill, 13 mm; CareFusion Item Number: VM85-1251; Lot Number: 050111.   5) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Boss Instruments; Boss Instruments Product Name: McKenzie Perforator Drill, 13 mm; Boss Instruments Item Number: 74-0140; Lot Number: 070412.", "firm_fei_number": "1421101", "recalling_firm": "Instrumed International, Inc.", "address_1": "626 Cooper Ct", "city": "Schaumburg", "state": "IL", "postal_code": "60173-4537", "additional_info_contact": "Ms. Jennifer S. Staunton\n847-908-6119", "reason_for_recall": "The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as \"Pre-Amendment\" devices.", "root_cause_description": "No Marketing Application", "action": "Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.", "product_quantity": "4 McKenzie perforator drills", "distribution_pattern": "Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.", "openfda": { "k_number": [ "K022370", "K162884", "K892531", "K153587", "K902818", "K862160", "K932402", "K160129", "K904283", "K022712", "K874952", "K915546", "K122456", "K875018", "K151536", "K961113", "K252696" ], "registration_number": [ "3003080184", "3014334038", "3018094310", "3006554912", "1043653", "8010405", "8010168", "2029275", "3012507533", "3010041511", "2031093", "9611274", "8010303", "1220477", "3004215117", "8040179", "1836161", "3015399803", "9611112", "8040233", "3009865268", "3015531529", "3013557562", "3016577622", "8010769", "3011137372", "1423714", "3023852420", "1721676", "8030607", "3008102049", "3008812560", "3003418325", "3034676720", "2031917", "1319639", "3003730855", "3011689956", "9680515", "1923569", "2023988", "3028006458", "3004608878", "9614945", "1417592", "8010300", "3007773213", "1722447", "3009417901", "3008868758", "2011171", "3005809810", "2183456", "2183319", "9710524", "8044098", "3005067367" ], "fei_number": [ "3003080184", "3014334038", "3018094310", "3006554912", "1043653", "3004028763", "3003944071", "3012507533", "3010041511", "1000138054", "1220477", "3004215117", "4439", "7282", "3006509795", "3008782585", "3546", "1000306431", "3015399803", "3002808043", "3002806452", "3009865268", "3015531529", "3013557562", "3016577622", "3001236549", "1000138491", "3005969827", "3023852420", "3002929183", "1721676", "3004207793", "3008102049", "3008812560", "3003418325", "3034676720", "3005747797", "3000719482", "1000453845", "3002750084", "3011689956", "4442", "3003730855", "3008237805", "1923569", "3028006458", "3004608878", "1417592", "3003499455", "3007773213", "3009417901", "3008868758", "2011171", "3005809810", "2183456", "2183319", "2023988" ], "device_name": "Drills, Burrs, Trephines & Accessories (Manual)", "medical_specialty_description": "Neurology", "regulation_number": "882.4300", "device_class": "2" } } ] }