{ "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": 36 } }, "results": [ { "cfres_id": "196024", "product_res_number": "Z-0008-2023", "event_date_initiated": "2022-08-30", "event_date_posted": "2022-10-06", "recall_status": "Open, Classified", "res_event_number": "90842", "product_code": "JDR", "k_numbers": [ "K191463" ], "product_description": "Hammertoe Continuous Compression Implant (CCI) Kit\nPart Number: 46.239.001", "code_info": "UDI-DI: 00810633022047\nLot Numbers: MHC220119, MHC220120\nExpiry Date: 1 June 2027", "firm_fei_number": "3008812560", "recalling_firm": "Synthes (USA) Products LLC", "address_1": "1301 Goshen Pkwy", "city": "West Chester", "state": "PA", "postal_code": "19380-5986", "reason_for_recall": "Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound", "root_cause_description": "Employee error", "action": "DePuy Synthes issued Urgent Medical Device Recall (Removal) letter on 8/30/22. Letter states reason for recall, health risk and action to take:\n1. Examine your inventory immediately to determine if you have the subject product and quarantine. DO NOT USE THE SUBJECT PRODUCT.\n2. Contact your DePuy Synthes Sales Consultant or call the customer support services at 1-800-255-2500 to coordinate the return/credits of the subject product.\n3. Review, complete, sign, and return the attached Business Response Form (page 3 of this letter) to OneMD-Field-Actions@its.jnj.com within 3 business days of receipt of this notification. Please include in the email subject: FA 2154225: 2022 Hammertoe CCI Kit.\n\" Please complete the attached Business Response Form even if you do not have the subject product on hand.\n4. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products).\n5. If any of the subject product has been forwarded to another facility, contact that facility and provide them with this notice.\n6. Post a copy of this notice in a visible area for awareness and keep a copy for your records.\nInquiries please do not hesitate to contact your DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.", "product_quantity": "191 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K023388", "K935065", "K203180", "K926037", "K232387", "K193305", "K911031", "K060014", "K143323", "K934867", "K041064", "K935321", "K061389", "K132875", "K061801", "K931182", "K102143", "K123926", "K945203", "K181781", "K905112", "K993714", "K052631", "K931519", "K130832", "K853704", "K190722", "K895117", "K921873", "K151615", "K924941", "K243742", "K012081", "K131061", "K911837", "K232990", "K950070", "K942889", "K932041", "K181866", "K023203", "K243888", "K840566", "K893203", "K964226", "K141550", "K874914", "K915889", "K941029", "K903271", "K903022", "K141263", "K894929", "K181815", "K071477", "K081098", "K173775", "K112837", "K102107", "K991566", "K182212", "K173693", "K961585", "K951658", "K231493", "K961578", "K911026", "K000797", "K232324", "K231458", "K230550", "K140358", "K124045", "K220812", "K905363", "K061798", "K143037", "K950272", "K944936", "K920213", "K896471", "K930892", "K162354", "K160813", "K832884", "K953764", "K911445", "K073281", "K133844", "K003033", "K023417", "K261121", "K981798", "K902567", "K071479", "K935167", "K230724", "K080111", "K181410", "K941772", "K905362", "K142292", "K182943", "K221947", "K102387", "K210582", "K903273", "K151762", "K051989", "K242415", "K946346", "K071637", "K041115", "K892126", "K172205", "K060746", "K060553", "K161587", "K070688", "K020948", "K072298", "K222645", "K240212", "K063273", "K162321", "K952348", "K897155", "K931782", "K142727", "K210456", "K250712", "K142148", "K982420", "K143622", "K191636", "K243658", "K991482", "K060970", "K041116", "K965175", "K151160", "K061657", "K124022", "K163226", "K792204", "K904553", "K153395", "K172052", "K930967", "K133780", "K123363", "K953276", "K926384", "K911293", "K911020", "K902751", "K924665", "K961555", "K142111", "K031127", "K010051", "K203832", "K190166", "K932925", "K180544", "K001354", "K192447", "K822943", "K861137", "K930893", "K890962", "K231885", "K904340", "K062734", "K161426", "K122113", "K943492", "K071257", "K853267", "K210482", "K163440", "K122871", "K873507", "K924367", "K962705", "K954443", "K170923", "K021953", "K910723", "K811500", "K043059", "K041117", "K061776", "K930538", "K953531", "K070031", "K011716", "K153622", "K172405", "K051408", "K191463", "K171473", "K924034", "K150125", "K153129", "K813567", "K070033", "K982996", "K943548", "K943950", "K931253", "K133270", "K830455", "K061594", "K942787", "K081172", "K153770", "K133523", "K926270", "K002695", "K223056", "K062170", "K041988", "K232905", "K962793", "K854445", "K220181", "K082215", "K041065", "K913461", "K991962", "K905364" ], "registration_number": [ "3010331645", "3012358417", "1038671", "3008812251", "3009973699", "3027071765", "3004915132", "3013820441", "3014527966", "1220477", "1051526", "3013055499", "8030965", "3018094310", "2244478", "3014004349", "3014302784", "3002807310", "1222928", "1649518", "3023808054", "3012966183", "3031240334", "3015542154", "1450662", "3007420745", "3007993775", "3010400367", "3011580264", "3017196117", "3019356409", "3027848094", "3002579136", "3039081660", "1048735", "3015718210", "3002807315", "3041276415", "3002949614", "3012478585", "2030624", "3008559295", "2031009", "1835296", "3006498370", "2936485", "3021336182", "3026586698", "1833506", "3012818475", "1225838", "3007583504", "3010673850", "3008110533", "3015946784", "3010060157", "3009540749", "3007113169", "3009110133", "3002907620", "3004983210", "3002807295", "3007593722", "3012470322", "3033509898", "1720929", "2245304", "1824199", "3015806723", "3006017180", "1226544", "2032098", "3002807314", "1054811", "3011623994", "3023852420", "3015974593", "3011683674", "1721676", "1221934", "3008951116", "3020703621", "3011230048", "3030183061", "2320767", "3014262693", "3027242374", "2650143", "3008749819", "3008837339", "3015207155", "1833986", "3003387384", "3020584246", "1423662", "3015173212", "1219930", "2183967", "3010673777", "3009417901", "3016084569", "3010041499", "8010944", "3011301313", "3010047402", "1043653", "3012329552", "3013365802", "1030489", "3019807891", "3017191784", "1417592", "8043792", "3005497913", "3004976965", "3014314623", "3015231789", "2530154", "1058584", "3013700547", "3008868758", "3027339877", "1834379", "3020704423", "3012275107", "3013011598", "3015780293", "1649390", "3006638824", "1526534", "3006460162", "9614209", "3007503337", "3013176080", "3030627814", "3002719998", "2183946", "3008236846", "3011874600", "3004464325", "3015183635", "3010273872", "3005180920", "2028632", "1000461041", "1833920", "9710629", "9681465", "3015200653", "3000203391", "1220246", "3010041511", "3003139373", "3009631939", "3024021261", "3004638532", "3015539532", "1647149", "8044102", "2246552", "3015440604", "3010123172", "1219602", "3010041420", "1017294", "1047843", "3010622588", "9615765", "3032588003", "9617083", "3010041430", "1018470", "3007663067", "1835831", "3007125392", "3003604053", "3014967969", "3017210488", "3006783837", "1825034", "1424263", "3009116370", "3038503932", "3009423112", "2029275", "3010667733", "3016727307", "3008650117", "3010470577", "3004579081", "3017980495", "3015200759", "3010389204", "2027754", "3021393544", "3009882462", "3026576110", "1319660", "1020279", "3025141", "3008034554", "3010123256", "9610622", "2648666", "3007366790", "3016248538", "3010162973", "3010178296", "8010257", "3014273424", "3007289093", "3005941719", "3009513193", "3009746186", "1061927", "3003236702", "3010041693", "3008812560", "3003477135", "3009971621", "3009812190", "3020899789", "8031020", "3011296511", "3006272282", "3025603301", "3036756245", "3016851379", "3003755939", "1828288", "3012883081", "1043534", "3010052483", "3027534459", "1226183", "3010462278", "3004365956", "3005827567", "3035366890", "3008114965", "3011302058", "1526711", "3034676720", "3019269298", "3031160399" ], "fei_number": [ "3010331645", "3012358417", "1000219637", "1038671", "3001236277", "3009973699", "3027071765", "3004915132", "3013820441", "3014527966", "1220477", "3003015552", "3002807305", "1051526", "3013055499", "3018094310", "1000139987", "3014004349", "3014302784", "3002807310", "3007282753", "3023808054", "3015542154", "3012966183", "3031240334", "1450662", "3007420745", "3007993775", "3010400367", "3011580264", "3017196117", "3019356409", "3027848094", "3002579136", "3039081660", "1048735", "3002757549", "3015718210", "3002807315", "3041276415", "3002949614", "3012478585", "1000306431", "1000115735", "3008559295", "3001644153", "3006498370", "2936485", "3021336182", "3026586698", "3012818475", "3007583504", "3010673850", "3008110533", "3015946784", "1000307073", "3010060157", "3009540749", "1832656", "3007113169", "3009110133", "3002907620", "3004983210", "3002807295", "3007593722", "3012470322", "3033509898", "1720929", "2245304", "1824199", "3015806723", "3006017180", "3002807314", "3000210784", "3011623994", "3023852420", "3015974593", "3011683674", "1721676", "1221934", "3008951116", "3020703621", "3011230048", "3030183061", "3014262693", "3027242374", "3008749819", "1000306303", "3008837339", "3015207155", "3003387384", "3009322142", "3020584246", "1000125025", "3015173212", "1219930", "3010673777", "3009417901", "3016084569", "3000203000", "3011301313", "3010047402", "3000215273", "1043653", "3003407235", "3012329552", "3013365802", "3000718467", "3019807891", "3017191784", "1417592", "3003756816", "3005497913", "3004976965", "3014314623", "3002808293", "3015231789", "3013700547", "3008868758", "3027339877", "3008647423", "3002806545", "1000116116", "3012275107", "3013011598", "3015780293", "3020704423", "1000306139", "3002807231", "3006460162", "3006638824", "1526534", "3007503337", "3013176080", "3003056094", "3030627814", "3002719998", "3008236846", "3011874600", "3004464325", "3002806534", "3015183635", "3010273872", "4498", "3001236812", "3005180920", "1000461041", "3015200653", "3000203391", "3013299874", "1220246", "3010041511", "3001814066", "3003128516", "1000136478", "3003139373", "3009631939", "3024021261", "3004638532", "3015539532", "2246552", "3015440604", "1000114185", "1000125930", "3010123172", "1219602", "3010041420", "1017294", "1047843", "3010622588", "3032588003", "3010041430", "1018470", "1000115656", "3007663067", "3002807830", "3007125392", "3003604053", "3014967969", "1000120613", "3002808269", "3017210488", "1825034", "3009116370", "3003058448", "3038503932", "3009423112", "3010667733", "3016727307", "3022270316", "3008650117", "3010470577", "3004579081", "3017980495", "3015200759", "3010389204", "2027754", "3021393544", "3009882462", "3026576110", "1020279", "3008034554", "3010123256", "2648666", "3016248538", "3007289093", "3014273424", "2648209", "3009513193", "3009746186", "3002807113", "3003236702", "3010041693", "3008812560", "3003477135", "3009971621", "3002807041", "3020899789", "3011296511", "3002807111", "3006272282", "3025603301", "3036756245", "3016851379", "3003755939", "1828288", "3012883081", "1043534", "3010052483", "3027534459", "1000477302", "3010462278", "1000136269", "3004365956", "3002806725", "3005827567", "3035366890", "3008114965", "3011302058", "1526711", "3000206435", "3034676720", "3003110073", "3019269298", "3031160399" ], "device_name": "Staple, Fixation, Bone", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3030", "device_class": "2" } } ] }