{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "191591", "product_res_number": "Z-0635-2022", "event_date_initiated": "2021-12-14", "event_date_created": "2022-02-10", "recall_status": "Open, Classified", "res_event_number": "89443", "product_code": "KQZ", "product_description": "Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures\nProduct Number: 72205104", "code_info": "Lot Numbers:\n50971615, 50971617 & 50967788", "firm_fei_number": "1020279", "recalling_firm": "Smith & Nephew, Inc.", "address_1": "1450 E Brooks Rd", "city": "Memphis", "state": "TN", "postal_code": "38116-1804", "additional_info_contact": "SAME\n901-396-2121", "reason_for_recall": "Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process", "root_cause_description": "Nonconforming Material/Component", "action": "Smith & Nephew issued Urgent Medical Device (R-2021-11) on 12/14/21 to Hospitals via FedX, to Sales rep. and Foreign Distributor via email.. An updated letter issued 1/14/22 to correct a batch number clerical error. Letters state reason for recall, health risk and action to take:\n1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately.\na. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete.\nb. Include the customer s account number and name in the table below.\n2. If you have no product to return, please put an X in the appropriate location below.\n3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below.\n4. Complete the remainder of the form, sign and send to FieldActions@smith-nephew.com.\nPlease Note even if you have no product to return, this form must be completed, signed and returned.\n5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number.\nIf you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.", "product_quantity": "271 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.", "openfda": { "k_number": [ "K871296", "K802869", "K823660", "K823163", "K871900", "K884132", "K854270", "K821252", "K831002", "K781754", "K882640" ], "registration_number": [ "3016678045", "3033530430", "3043013796", "1219602", "3012257692", "3010536692", "3012130008", "1223962", "2182345", "3009936738", "3015806723", "2321033", "3012883081", "2530138", "3027339877", "1647149", "3013957847", "3004905643", "3007663056", "3032391", "3006210673", "1421879", "8031020", "3011295718", "8030607", "2320762", "3008008970", "3020468145", "3010675856", "1218386", "1836161", "3016443334", "1000649241", "1026765", "1526534", "3015974593", "3021393544", "1928237", "3005180920", "8022890", "3012358417", "3009610508", "3014936223", "3010667733", "3020899789", "1833053", "9616086", "3010452421", "1420032", "3010380518", "3010097863", "3013404959", "3016851379", "1835998", "3045857302", "1058584", "1043534", "3003890514", "9681161", "3030680364", "1320894", "3007299770", "3007886583", "2921578", "3004369035", "3005893246", "3013004243", "3014643275", "3021336182", "3008048783", "3010273872", "3012329552", "3030926959", "3007319107", "8010100", "1055236", "3003604053", "3040389283", "3016727307", "3002579136", "1423537", "3042898206", "3010987649", "9680579", "1054811", "1043214", "1825034", "3003781173", "3014004349", "1064017", "3008110533", "1058152", "3014982318", "3017264244", "1054241", "3008770252", "3019269298", "3043149162", "3013700547", "3021226419", "3021656665", "9680825", "3045752480", "3010331645", "1824206", "3015539532", "3012818475", "1220246", "3030531648", "3033849261", "3011715925", "1643264", "1220477", "3007731000", "3020704423", "3030681106", "3011230048", "3005273623" ], "fei_number": [ "3016678045", "3033530430", "3043013796", "3001451571", "1219602", "3012257692", "1000112877", "3010536692", "3012130008", "2182345", "3009936738", "3015806723", "3012883081", "3027339877", "3013957847", "1000114185", "3004905643", "3002807830", "3007663056", "3006210673", "3011295718", "3008008970", "3020468145", "3010675856", "1218386", "3016443334", "1000649241", "1026765", "1526534", "3015974593", "3021393544", "1928237", "3005180920", "1000306139", "3012358417", "3009610508", "3014936223", "3010667733", "3020899789", "1833053", "3010452421", "1420032", "3010380518", "3010097863", "3016851379", "3045857302", "1043534", "3003890514", "1000219637", "3030680364", "3007299770", "3007886583", "2921578", "3004369035", "1000518604", "3005893246", "3006076154", "3003640911", "3001236905", "3013004243", "3014643275", "3021336182", "1000112968", "3926", "3008048783", "3010273872", "3006509795", "1000508772", "3002750084", "3012329552", "3030926959", "3007319107", "3003399881", "1000222089", "3000190635", "3002807827", "3003604053", "3040389283", "3016727307", "3002579136", "1000305774", "3042898206", "3010987649", "3008747867", "1043214", "1825034", "3003781173", "3014004349", "3008110533", "3014982318", "3017264244", "3008770252", "3019269298", "3043149162", "3013700547", "3021226419", "3021656665", "1000115048", "3045752480", "3002299608", "3003040625", "3010331645", "1824206", "3015539532", "3012818475", "1220246", "3030531648", "3033849261", "3011715925", "1643264", "1000221205", "1220477", "3007731000", "3020704423", "3030681106", "1000203464", "3011230048", "3005273623" ], "device_name": "Component, Traction, Non-Invasive", "medical_specialty_description": "Orthopedic", "regulation_number": "888.5890", "device_class": "1" } } ] }