{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "131539", "product_res_number": "Z-0492-2015", "event_date_initiated": "2014-10-17", "event_date_posted": "2015-01-09", "recall_status": "Terminated", "event_date_terminated": "2015-08-14", "res_event_number": "69787", "product_code": "GAP", "k_numbers": [ "K946173" ], "product_description": "Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.", "code_info": "PERMA-HAND\" Silk Suture [Siliconized black braided] Product Code - 10Q06  Lots and Expiration Dates-  GPP528 JUL 2018  GPP908 JUL 2018  HAB605 JAN 2019  HAE019 JAN 2019  HAE964 JAN 2019  HAP987 JAN 2019  HBB681 JAN 2019  HBB952 JAN 2019  HBE186 JAN 2019  HCB084 JAN 2019  HCB972 JAN 2019  HCE266 JAN 2019  HCE980 JAN 2019   PERMA-HAND\" Silk Suture [Siliconized black braided]  Product Code - 10Q07  Lots and Expiration Dates-  GPB984 JUL 2018  GPE919 JUL 2018  HAP822 JAN 2019  HBP781 JAN 2019  HCP953 JAN 2019  HCR677 JAN 2019", "firm_fei_number": "2210968", "recalling_firm": "Ethicon, Inc.", "address_1": "US Highway 22 West", "city": "Somerville", "state": "NJ", "postal_code": "08876", "additional_info_contact": "877-384-4266", "reason_for_recall": "Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.", "root_cause_description": "Other", "action": "Ethicon sent an Urgent Medical Device Recall Letter/Business Reply Form dated 10/17/2014 via UPS next day mail.", "product_quantity": "2,508 each", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K003001", "K931913", "K904478", "K232355", "K904891", "K053638", "K930825", "K980124", "K993999", "K222944", "K981128", "K023029", "K012124", "K080684", "K905287", "K760158", "K930739", "K760650", "K942234", "K001184", "K162396", "K024091", "K241486", "K905454", "K180701", "K960328", "K943627", "K221767", "K041514", "K990089", "K994177", "K042282", "K761199", "K964581", "K020901", "K982853", "K930826", "K071111", "K000541", "K172149", "K160623" ], "pma_number": [ "N80989", "N84348", "N84047", "N85143", "N11397" ], "registration_number": [ "3013403214", "2210968", "1058584", "3013298431", "3003418325", "3015183635", "3014592276", "3015806723", "3009423112", "3013700547", "9710098", "9611459", "3008912461", "3017196117", "2648623", "3004215117", "2183301", "3006498370", "3015330532", "3044819802", "1220246", "3009513193", "3002692886", "3010864832", "3029901632", "9612501", "3016851379", "3014276972", "3014615644", "3019269298", "3018094310", "3018052045", "3045857302", "3043226252", "3010692967", "3004111573", "1017294", "2530154", "1048735", "3002579136", "3004365956", "3017102971", "3021226419", "3005953126", "1000274611", "3014461810", "9616088", "1037089", "3015231789", "1018470", "3010041511", "1450662", "1061927", "1221601", "3003639970", "1219930", "3010452421", "2648650", "3030733800", "3012329552", "3027339877", "1054811", "3011276344", "3012494290", "3012421607", "3004117249", "3007205024", "1423537", "1043214", "1721676", "3014004349", "3010131137", "3004192065", "3038718579", "3013187142", "1066741", "3045855232", "3008483449", "3010331645", "1061124", "1062741", "3014262693", "3004944585", "3032543753", "3012502601", "3006638824", "3015859709", "2523835", "3029754081", "3006562124", "1055236", "3011230048", "3010400367", "3016727307", "2032098", "1064584", "2521877", "3016904853", "3007791573", "3016426842", "3012101664", "3003267729", "3027242374", "3006981798", "3011689956", "3014273254", "3015974593", "3007791599", "3004845555", "3007109793", "1064017", "1221051", "1064514", "2030624", "3020704423", "1054241", "9680794", "3010162973", "3011137372", "2320762", "3006425876", "3009968482", "3014579161", "3020983460" ], "fei_number": [ "3013403214", "2210968", "3002902735", "1000219637", "3005747797", "3002957101", "3001236905", "3013298431", "3003418325", "3015183635", "3014592276", "3015806723", "3009423112", "3003040625", "3013700547", "3008912461", "3000206435", "3017196117", "2648623", "3004215117", "2183301", "3006498370", "3015330532", "3044819802", "1220246", "3009513193", "3002692886", "1000307073", "3002807041", "3029901632", "3000302153", "3016851379", "3014276972", "3014615644", "3019269298", "3018094310", "3003063934", "3018052045", "3045857302", "3043226252", "3010692967", "3004111573", "1017294", "3004161528", "1048735", "3002579136", "3004365956", "3017102971", "3021226419", "3005953126", "1000274611", "3014461810", "1037089", "3015231789", "1018470", "3010041511", "1450662", "3003058448", "1221601", "3003639970", "1219930", "3010452421", "2648650", "3030733800", "3012329552", "3003495548", "3027339877", "3011276344", "3012494290", "3012421607", "3002807993", "3004117249", "1000114185", "3007205024", "1043214", "1000112968", "1721676", "3014004349", "3010131137", "3004192065", "3038718579", "3013187142", "1000512168", "3003737899", "3045855232", "3008483449", "3003005156", "3010331645", "3014262693", "3004944585", "3032543753", "3012502601", "3010862763", "3006638824", "3000203000", "3015859709", "2523835", "3029754081", "3006562124", "3011230048", "1000112877", "3010400367", "3016727307", "3000190635", "2521877", "3016904853", "3007791573", "3016426842", "3012101664", "3003267729", "3027242374", "3006981798", "3011689956", "3014273254", "3015974593", "3007791599", "3004845555", "3007109793", "1221051", "3020704423", "3006425876", "3009968482", "3014579161", "3020983460" ], "device_name": "Suture, Nonabsorbable, Silk", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5030", "device_class": "2" } } ] }