{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 15 } }, "results": [ { "cfres_id": "113646", "product_res_number": "Z-0168-2013", "event_date_initiated": "2012-09-25", "event_date_posted": "2012-10-29", "recall_status": "Terminated", "event_date_terminated": "2013-03-29", "res_event_number": "63385", "product_code": "MNH", "k_numbers": [ "K042673", "K071890" ], "product_description": "ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System,\nOrthosis, Spinal Pedical Fixation\nOrthosis, Spondylolisthesis Spinal Fixation\n\n\nThe ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. When used for a minimally invasive posterior approach ILLlCO MIS Instrumentation is used in conjunction with polyaxial screw components. The ILLICO MIS Posterior Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the ILLICO MIS Posterior Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.", "code_info": "Product Codes: KW, MNI, MNH.  Part NumberlLot Number: ¿PART DESCRIPTION LOT \t  7384S-30 \tTi CANNULATED POLYAXIAL SCREW 4.5mm X 30mm \t646501 \t\t  73845-35 \tTi CANNULATED POLYAXIAL SCREW 4.5mm X 35mm \t646502 \t  73845-40 \tTi CANNULATED POLYAXIAL SCREW 4.5mm X 40mm \t646503 \t  73845-45 \tTi CANNULATED POLYAXIAL SCREW 4.5mm X 45mm \t646504 \t  73855-35 \tTi CANNULATED POLYAXIAL SCREW 5.5mm X 35mm \t646510 \t  73865-30 \tTi CANNULATED POLYAXIAL SCREW 6.5mm X 30mm \t646515 \t  73865-35 \tTi CANNULATED POLYAXIAL SCREW 6.5mm X 35mm \t646516 \t  73865-40 \tTi CANNULATED POLYAXIAL SCREW 6.5mm X 40mm \t646517 \t  73865-45 \tTi CANNULATED POLYAXIAL SCREW 6.5mm X 45mm \t646542 \t  73865-50 \tTi CANNULATED POLYAXIAL SCREW 6.5mm X 50mm \t646543 \t  73875-35 \tTi CANNULATED POLYAXIAL SCREW 7.5mm X 35mm \t646546 \t  73875-45 \tTi CANNULATED POLYAXIAL SCREW 7.5mm X 45mm \t646548 \t  73875-50 \tTi CANNULATED POLYAXIAL SCREW 7.5mm X 50mm \t646549", "firm_fei_number": "2027467", "recalling_firm": "Alphatec Spine, Inc.", "address_1": "5818 El Camino Real", "city": "Carlsbad", "state": "CA", "postal_code": "92008-8816", "additional_info_contact": "760-431-9286", "reason_for_recall": "The firm initiated the recall because the stainless steel guide-wire of the\nIllico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti\nCannulated Polyaxial Screws, therefore rendering such screws nonfunctional.", "root_cause_description": "Nonconforming Material/Component", "action": "Alphatec Spine sent an Urgent Medical Device Recall Notification letter dated September 25, 2012, to all affected customers. The letter identifed the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Alphatec Spine's Customers Service Department (customerservice@alphatecspine.com) immediately for instructions on how to return the affected product. Customers were asked to fill out the lower portion of the letter and fax to (760) 431-0289 to confirm that they have read the notification and will take all necessary removal actions. For questions customers were instructed to call 1-800-922-1356. For questions regarding this recall call 760-431-9286.", "product_quantity": "209 screws", "distribution_pattern": "Nationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT.", "openfda": { "k_number": [ "K133575", "K080876", "K945064", "K123487", "K031585", "K013295", "K023378", "K984302", "K061778", "K061915", "K053573", "K940631", "K024348", "K120491", "K130267", "K951308", "K040747", "K120353", "K103573", "K003384", "K061577", "K963045", "K150283", "K002399", "K111370", "K031290", "K962784", "K161151", "K000020", "K953779", "K951172", "K140053", "K142957", "K990118", "K974213", "K971970", "K981714", "K111940", "K101446", "K151695", "K091110", "K010845", "K132403", "K020681", "K993551", "K951626", "K151116", "K010742", "K953915", "K950695", "K991031", "K080611", "K014229", "K003463", "K020356", "K082509", "K950596", "K010249", "K011182", "K990721", "K090424", "K081165", "K930353", "K121016", "K051286", "K001024", "K081883", "K946348", "K091725", 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