{ "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": "94547", "product_res_number": "Z-0082-2011", "event_date_initiated": "2010-08-13", "event_date_posted": "2010-10-18", "recall_status": "Terminated", "event_date_terminated": "2011-09-21", "res_event_number": "56805", "product_code": "KWZ", "k_numbers": [ "K083566" ], "product_description": "R3 (TM) 22 MM I.D., 58 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339158, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component.\nAcetabular Liner", "code_info": "All lots", "firm_fei_number": "1020279", "recalling_firm": "Smith & Nephew Inc", "address_1": "1450 E. Brooks Rd", "city": "Memphis", "state": "TN", "postal_code": "38116", "additional_info_contact": "Victor Rocha\n901-399-6771", "reason_for_recall": "The firm received reports of a femoral head popping out of the liner intraoperatively.", "root_cause_description": "Other", "action": "Smith & Nephew notified all distributors via e-mail and sent a letter dated August 13, 2010 to all hospitals notifying them of the product, the problem, and the action to be taken. \n1) Distributors were to immediately cease distribution and use of the product, examine their stock and the stock of the accounts they supplied if applicable and remove any affected devices from all inventories and place them into quarantine to prevent accidental distribution. \n2) Identify customers that received these products and immediately notify them of the recall.\n3) Carry out a physical count and record the data on the Verification Section included in the letter.\n4) Contact their inventory specialist for an RA# and record this on the Verification Section.\n5) Return the Verfication Section even if they do not have the recalled product.\n6) Return the recalled product to:\n Smith & Nephew, Inc.\n Attn: Return Goods\n 3303 Holmes Road\n Memphis, TN 38118\nSmith & Nephew, Inc. sent a second notice via e-mail on 09/03/2010 to non-responding distributors and by Fed Ex to the hospitals 09/21/2010.\n\nFor any questions regarding this recall customers were to call (901) 399-5441.", "product_quantity": "82 units", "distribution_pattern": "Worlwide Distribution, USA including AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, WA, and WI and the countries of Australia and Portugal", "openfda": { "k_number": [ "K161610", "K021826", "K071117", "K162641", "K803192", "K063445", "K240639", "K023794", "K063552", "K030923", "K083566", "K071059", "K021803", "K040225", "K021661", "K061654", "K122139", "K040601", "K111635", "K072121", "K021728", "K071718", "K071676", "K890197", "K043058", "K163497", "K870271", "K033442", "K101730", "K063550", "K950202", "K030047", "K241461", "K052079" ], "pma_number": [ "P960054", "P960047" ], "registration_number": [ "1038671", "3008812251", "1644408", "1220477", "3010065126", "3010163695", "3013055499", "3007120646", "3008021110", "3005718816", "9614841", "3014302784", "3002807310", "1649518", "3015542154", "3007200272", "3013014058", "1450662", "3005323511", "2242737", "3003639920", "3002807315", "3010206549", "3010173425", "9613369", "3002806470", "1531174", "2528981", "3008668801", "3008110533", "3011295718", "2249697", "3002907620", "3033509898", "1828464", "2245304", "3006017180", "2531477", "1221763", "3002807314", "1835251", "1645151", "3023852420", "3011683674", "3008102042", "1721676", "3009241418", "3015207155", "3010537287", "1834331", "1833986", "3003387384", "3003998208", "3004635447", "1423662", "3010386387", "1000577893", "3003595343", "3010009693", "1043653", "3004748528", "1529009", "3016438694", 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