{ "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": 1 } }, "results": [ { "cfres_id": "189139", "product_res_number": "Z-0072-2022", "event_date_initiated": "2021-09-13", "event_date_created": "2021-10-07", "recall_status": "Terminated", "event_date_terminated": "2024-01-29", "res_event_number": "88636", "product_code": "BWN", "product_description": "ARCH Leg Positioning System", "code_info": "Model: 6813010\nSerial Numbers:\n6813010.0066;\n6813010.0067;\n6813010.0069;\n6813010.0070;\n6813010.0071;\n6813010.0072;\n6813010.0073;\n6813010.0074;\n6813010.0075;\n6813010.0076;", "firm_fei_number": "3006119126", "recalling_firm": "Innovative Orthopedic Technologies, LLC", "address_1": "1115 Highway 124", "city": "Winnie", "state": "TX", "postal_code": "77665", "additional_info_contact": "Suzanne Janacek\n409-658-1017", "reason_for_recall": "Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.", "root_cause_description": "Device Design", "action": "On 09/13/2021, the firm sent via certified mail an \"URGENT: MEDICAL DEVICE RECALL\" Notification letter to customers informing them that the Leg Positioning System is being recalled due to a manufacturing defect that may make locking the flexion/extension carriage into position difficult under load.\n\nCustomers are instructed to:\n1. Contact the Recalling Firm to schedule repair of their device.\n2. While customers are waiting for the repair of their device, lifting the boot to lighten the load will pushing the locking pin into place can alleviate the issue.\n3. Complete and return the Acknowledgement and Receipt Form to the Recalling Firm by email or mail.\n\nThe actions the Recalling Firm is taking:\n1. Correcting the issue by temporarily replacing the affected part with an unaffected part while the affected part is being repaired. The repair will be taking place at the Recalling Firm's facility.\n2. Implementing an additional functional test that will test the product under load.\n\nFor questions and to schedule repair, contact:\nSuzanne Janacek, Operations Director - 409-658-1017 Monday through Friday 8:00 AM to 4:30 PM Central Time or email suzanne.janacek@iotiot.com\n\nor mail at 1115 Hwy 124, Winnie, TX 77665 email www.iotiot.com", "product_quantity": "10 units", "distribution_pattern": "U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX.", "openfda": { "k_number": [ "K875291", "K910783", "K935441", "K884558", "K832340", "K820574", "K812395", "K791859", "K823772", "K873272", "K802271", "K942699", "K925005", "K852332", "K843121", "K812396", "K860177", "K792569", "K922288", "K902865" ], "registration_number": [ "3010331645", "", "3004967902", "3007123908", "3037012186", "3024890239", "3017911818", "3014908171", "3014004349", "3019502344", "3011910987", "9610612", "3002579136", "1450428", "3016050940", "3014739961", "9613910", "8021896", 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