{ "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": "167446", "product_res_number": "Z-0200-2019", "event_date_initiated": "2018-09-18", "event_date_created": "2018-10-22", "recall_status": "Terminated", "event_date_terminated": "2019-05-08", "res_event_number": "81100", "product_code": "MBH", "k_numbers": [ "K121393" ], "product_description": "Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1)\n\nThe LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.", "code_info": "Lot 17LM05396", "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": "901-396-2121", "reason_for_recall": "One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.", "root_cause_description": "Process control", "action": "The firm, Smith & Nephew, notified their consignees with a notice entitled \" Urgent Medical Device Recall Notice\" by email on 09/18/2018. The notice The notice explained the problem and the potential hazard and requested return of the recalled units. The consignees are instructed to do the following:\nPlease inspect your inventory and locate any devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately.\na. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out.\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 remainders of the form sign and send to FieldActions@smith-nephew.com or fax to 901-566-7975.\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.\n\nIf you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.", "product_quantity": "6 units", "distribution_pattern": "US Distribution to the states of: KS and TN.", "openfda": { "k_number": [ "K141635", "K123459", "K080842", "K053340", "K143366", "K210308", "K242543", "K122745", "K202194", "K252777", "K031462", "K162256", "K032108", "K181794", "K172634", "K200782", "K233507", "K051380", "K153776", "K061223", "K212941", "K063731", "K140075", "K243768", "K060303", "K253189", "K253239", "K250980", "K153586", "K143393", "K253161", "K041872", "K170288", "K032905", "K223316", "K140883", "K141056", "K123486", "K120990", "K140881", "K150090", "K061521", "K242412", "K071107", "K243615", "K140735", "K033971", "K043083", "K253637", "K191084", "K051510", "K222566", "K063128", "K030612", "K140257", "K171365", "K211221", "K080361", "K122160", "K221705", 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