{ "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": "105380", "product_res_number": "Z-0447-2012", "event_date_initiated": "2011-07-08", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2012-03-09", "res_event_number": "60421", "product_code": "HBF", "product_description": "Box labeled in part, \"REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5\")(L) RABALON, STAINLESS STEEL, GOLD PLATED***NON-STERILE PRODUCT*** MADE IN THE PHILIPPINES*** BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***\"\n\nThe Biomet Microfixation IQ Intelligent Driver is a handheld cordless device designed for three functions: drill pilot holes, high-speed insertion of 1.5x4mm titanium screws, and high-speed insertion of 1.5x4mm and 1.5x5mm Lactosorb fixation screws provided by Biomet Microfixation. The IQ Intelligent Driver is indicated to aid in the implantation of screws (Drilling holes and inserting screws).", "code_info": "Model #- 72-1000 Serial #'s: 000007, 000009, 000010, 000011, 000012, 000013, 000017, 0G0014, 0G0018, 0G0019, 0K0001, 0K0003, 0K0006, 0K0007, 0K0008, 0K0009, 0K0011, 0K0012, 0K0013, 0K0014, 0K0015, 0K0016, 0K0017, 0K0019, 0K0020, 0K0021, 0K0022, 0L0001, 0L0002, 0L0003, 0L0004, 0L0005, 0L0006, 0L0007, 0L0008, 0L0009, 0L0010, 0L0011, 0L0014, 0L0015, 0L0016, 0L0017, 0L0018, 0L0019, 0L0020, 0L0022, 0L0023, 0L0024, 0L0026, 0L0028, 0L0029, 0L0030, 0L0031, 0L0032, 0L0033, 0L0034, 0L0035, 0L0037, 0L0038, 0L0039, 0L0041, 0L0042, 0L0044, 0L0045, 0L0046, 1A0004, 1A0005, 1A0012, 1A0014, 1A0016, 1A0019, 1A0020, 1A0021, 1A0022, 1A0024, 1A0026, 1A0028, 1A0031, 1A0033, 1A0034, 1A0036, 1A0037, 1A0041, 1A0042, 1A0043, 1A0044, 1A0046, 1A0047, 1A0048, 1A0051, 1A0052, 1A0053, 1A0055, 1A0056, 1A0057, 1A0059,1A0062, 1A0064, 1A0067, 1A0069, 1A0070, 1A0072, 1A0073, 1A0079, 1A0081, 1A0084, 1A0085, 1A0086, 1A0088, 1A0089, 1A0090, 1A0091, 1A0093, 1A0095, 1A0096, 1A0097, 1A0098, 1A0099, 1A0100, 1A0101, 1A0102, 1A0103, 1A0105, 1A0106, 1A0107, 1A0108, 1A0113, 1A0117, 1A0118, 1A0119, 1A0120, 1A0123, 1A0125, 1A0126, 1A0127, 1A0128, 1A0129, 1A0130, 1A0131, 1A0133, 1A0134, 1A0135, 1A0136, 1A0137, 1A0138, 1A0142, 1A0144, 1A0145, 1A0148, 1A0149, 1A0152, 1A0153, 1A0156, 1A0158, 1A0171, 1A0174, 1A0176, 1A0198, 1B0010, 1C0004, 1C0014, 1C0023, 1C0025, CK 0030, cK0011, CK0024, CK0025, CK0026, CK0027, CK0028, CK0029, CK0032, CK0033", "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": "Christy Cain\n904-741-4400", "reason_for_recall": "Biomet Microfixation, Inc., Jacksonville, FL, recalled their IQ Intelligent Device, 72-1000 due to failure of the front bit sensor to detect the correct bit that is installed. When a screw is inserted with the device in drill mode, it is possible for the screw or bone to strip.", "root_cause_description": "Component design/selection", "action": "Biomet Microfixation called, emailed, or sent an Urgent Medical Device Recall letter dated July 8, 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 remove the remaining device(s) at their facility and return immediately to PIVOT for the required software upgrade. Customers were also instructed to return the attached reconciliation form to:\nPIVOT International\n10916 Strang Line Road\nLenexa, KS 66215\nAttn: Julie Lawrence\n\nFor any questions regarding this recall call 1-800-874-7711 or 904-741-4400, ext 9468.", "product_quantity": "161 devices were distributed.", "distribution_pattern": "Worldwide Distribution - USA AZ, CA, CO, DC, FL, GA, HI, ID, IL, IN, KS, LA, NC, NH, NY, OK, OR, PA, TN, TX, and WI and the countries of Argentina, Brazil, France, Italy, Japan, South Africa, and Thailand.", "openfda": { "k_number": [ "K892866", "K791101", "K121253", "K183581", "K071931", "K820087", "K082637", "K875019", "K073336", "K924242", "K982991", "K231403", "K933894", "K833266", "K141455", "K032970", "K082010", "K213228" ], "registration_number": [ "3030733800", "1526534", "3012494290", "3012421607", "1058584", "9616696", "3005562917", "3007031059", "3003418325", "1045834", "9681465", "3010097171", "3014724561", "1828288", "3010370650", "3014334038", "3009417901", "3010173425", "3015967359", "3010726901", "1220477", "2030624", "3009732568", "3013557562", "3010155648", "3040335671", "3014579161", "1220724", "3010596852" ], "fei_number": [ "3030733800", "1526534", "1000219637", "3012494290", "3012421607", "3005562917", "3007031059", "3003418325", "3010165944", "1045834", "3010097171", "3014724561", "1828288", "3014334038", "3009417901", "3002807113", "3015967359", "3000206435", "3010726901", "1220477", "3003164255", "3009732568", "3002807036", "3013557562", "3010155648", "3040335671", "3014579161", "1220724", "3010596852" ], "device_name": "Drills, Burrs, Trephines & Accessories (Compound, Powered)", "medical_specialty_description": "Neurology", "regulation_number": "882.4305", "device_class": "2" } } ] }