{ "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": "30157", "product_res_number": "Z-0146-04", "event_date_initiated": "2003-10-13", "event_date_posted": "2004-07-20", "recall_status": "Terminated", "event_date_terminated": "2004-03-08", "res_event_number": "27597", "product_code": "DXT", "k_numbers": [ "K011811" ], "product_description": "KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. \nKyphon Catalog Number: A08A. The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation Syringe. This medical device is provided as an individual stand-alone package (which also contains an accessory locking syringe device) and as an individually packaged component of the KyphoPak Tray. The Inflation Syringe packaging and contents are identical whether provided as a stand-alone package or as a component of the KyphoPak Tray.", "code_info": "Merit Medical (Inflation Syringe): Part No.: K05-01290A, Lot Nos.:A284998, A282736*; Kyphon (Inflation Syringe), Catalog No.: A08A, Lot Nos.:\tA284998, A282736.  *Although Merit Medical''s notice of the recall involved three (3) lot numbers, one of the lots had already been returned by Kyphon to Merit Medical upon Kyphon''s discovery during incoming inspection that there was a problem with the packaging. So, Kyphon''s product removal only involved the two (2) additional lots of syringes, only portions of which were distributed to customers.", "firm_fei_number": "3004904811", "recalling_firm": "Kyphon Inc", "address_1": "1350 Bordeaux Dr", "city": "Sunnyvale", "state": "CA", "postal_code": "94089-1005", "additional_info_contact": "Beth Rothwell\n408-548-6500", "reason_for_recall": "Devices for which sterility may be compromised as evidenced by a loss of package integrity.", "root_cause_description": "Other", "action": "On October 13, 2003, all consignees were notified via letter and on-site visit by a Kyphon sales representative, informing them of the affected devices and providing instructions on the recall.", "product_quantity": "211 syringes", "distribution_pattern": "There were a total of 188 direct customers that received the recalled product distributed by Kyphon. There were 0 (zero) wholesaler dealers, distributors, retailers that received the recalled product distributed by Kyphon. The recalled product was distributed in the United States only. Recalled product was distributed by Kyphon to one VA hospital, VA Medical Center of San Diego, 3350 La Jolla Village Dr. San Diego, CA 92161. There were no shipments to foreign or Canadian distribution.", "openfda": { "k_number": [ "K182273", "K863537", "K911166", "K905819", "K033247", "K863596", "K934086", "K023183", "K182289", "K113133", "K020892", "K062168", "K000013", "K203004", "K140469", "K904212", "K061976", "K072886", "K170431", "K163084", "K844045", "K171698", "K873597", "K924116", "K140425", "K890292", "K910873", "K984088", "K875324", "K912944", "K142081", "K833138", "K142745", "K232388", "K012950", "K873410", "K911549", "K964642", "K823253", "K973230", "K051799", "K090621", "K092896", "K133189", "K171646", "K823920", "K230668", "K822536", "K971712", "K252652", "K962141", "K791793", "K082212", "K010390", "K960965", "K955685", "K252891", "K072696", "K071691", "K854310", "K152218", "K823356", "K042784", "K955381", "K875196", "K881521", "K143538", "K983826", "K133600", "K860204", "K920135", "K830754", "K252638", "K840281", "K883769", "K880987", "K093830", "K031483", "K923117", "K163054", "K984231", "K901382", 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"K152978", "K872981", "K933908", "K244038", "K850861", "K042744", "K873955", "K862547", "K951802", "K963982", "K190102", "K873687", "K241109", "K170279", "K955684", "K963071", "K902377", "K873173", "K895318", "K160190", "K833645", "K823192", "K252653", "K821401", "K884913", "K935668", "K910594", "K991557", "K904994", "K031339", "K150902", "K900034", "K944875", "K011991", "K020333", "K001663", "K993728" ], "registration_number": [ "3003898360", "3013764800", "2520313", "3003120897", "3003627840", "1000604079", "2243252", "3001650535", "9610849", "3018094310", "3013529745", "3013820501", "3014246639", "3003829571", "1526863", "1054241", "9610612", "1724474", "3004605321", "3009504230", "2032112", "3003768277", "8022210", "3007138831", "1518293", "3009196578", "3010009632", "2320762", "3004068971", "1928237", "1720929", "2134243", "3004080920", "3004111573", "3004727093", "3035858922", "2032098", "3009882464", "3008850249", "1721676", "3004050971", "2011171", "3003542872", "1061124", 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