{ "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": "105995", "product_res_number": "Z-0650-2012", "event_date_initiated": "2011-07-20", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2013-04-03", "res_event_number": "60225", "product_code": "GAM", "k_numbers": [ "K053636" ], "product_description": "MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan***\n\nFor use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.", "code_info": "Z098004500, Z098004800, Z098007200, Z108002501, and Z108006900.", "firm_fei_number": "3002692886", "recalling_firm": "Mani, Inc. - Kiyohara Facility", "address_1": "8-3 Kiyohara Industrial Park", "city": "Utsunomiya-shi", "state": "Tochigi-ken", "country": "Japan", "reason_for_recall": "Surgical sutures may be weak and may not function as intended during surgical procedures.", "root_cause_description": "Component change control", "action": "The manufacturer notified consignees by phone, via fax with a letter, and e-mail on 07/20/11. The letter asked customers to check their inventory for any of the affected product, and if they had any product remaining to place the amount in the list \"Returned.\" If there was no product left, then the amount used should be placed in the list \"Used.\" Customers needed to complete and sign the document, being sure to send it and any remaining product to the address provided. Credit would be issued once goods were received. If customers have questions, they should contact the firm.", "product_quantity": "497 boxes", "distribution_pattern": "Nationwide Distribution -- PA and FL.", "openfda": { "k_number": [ "K200392", "K930588", "K161726", "K052437", "K003017", "K252820", "K141625", "K132580", "K171001", "K905482", "K122734", "K021767", "K994001", "K041806", "K211792", "K962480", "K014021", "K951520", "K050771", "K082662", "K033762", "K062366", "K051415", "K930360", "K091087", "K061796", "K000037", "K102592", "K170166", "K093408", "K042141", "K173874", "K201996", "K953869", "K143584", "K072646", "K930772", "K040477", "K002190", "K965162", "K060801", "K171494", "K140039", "K072028", "K160564", "K232372", "K944110", "K140227", "K180625", "K010672", "K032586", "K043539", "K946271", "K042233", "K111442", "K060828", "K980704", "K163676", "K212810", "K032420", "K051700", "K161629", "K170661", "K253620", "K033746", "K040282", "K022664", "K053636", "K002639", "K122898", "K022269", "K080412", "K181320", "K032698", "K120556", "K183004", "K031286", "K072859", "K130735", "K011375", "K930746", "K013177", "K072229", "K130083", "K011372", "K984374", "K081002", "K041515", "K142061", "K963253", "K183183", "K202950", "K073493", "K023710", "K100257", "K990432", "K173043", "K072645", "K183001", "K123940", "K141558", "K142822", "K033115", "K013671", "K151200", "K042288", "K172659", "K944937", "K072644", "K981935", "K150717", "K221744", "K970863", "K200140", "K050845", "K974299", "K123409", "K050611", "K253852", "K072863", "K253394", "K972566", "K153611", "K022715", "K130737", "K991191", "K961997", "K964345", "K990951", "K233265", "K992088", "K970317", "K063462", "K142810", "K181652", "K980610", "K915835", "K141778", "K123836", "K221527", "K253530", "K173779", "K945285", "K081003", "K063536", "K951352", "K252743", "K192580", "K971208" ], "pma_number": [ "N18387", "N16881", "P840051" ], "registration_number": [ "3013403214", "3010860245", "3015453963", "2210968", "3013644499", "1058584", "3013298431", "3003418325", "1531174", "3014479313", "3014592276", "3010419931", "3011803381", "1423662", "3015542154", "3008114965", "9710098", "1825034", "9611459", "2125050", "3008912461", "3017196117", "2648623", "2650143", "3004215117", "2183301", "3015330532", "3007009755", "3044819802", "3002692886", "3005972890", "3010864832", "3029901632", "9612501", "3019924", "3014276972", "3014615644", "1720929", "3018094310", "3015489699", "3008879776", "3018052045", "3045857302", "3043226252", "3010692967", "3004111573", "3043225236", "3004431266", "3004365956", "3017102971", "1319660", "3014272734", "3005953126", "1000274611", "3014461810", "9681572", "9616088", "3008868758", "1037089", "3003595343", "3007006186", "1018470", "3010041511", "3006680097", "3011085362", "1221601", "3003639970", "1219930", "3005941719", "3010452421", "2648650", "3030733800", "3011276344", "1221934", "3012494290", "3012421607", "3004117249", "3001124136", "1320468", "3007205024", "3011683674", "1423537", "1043214", "1721676", "2020601", "3045857207", "3010131137", "3004192065", "3038718579", "3013187142", "1066741", "3045855232", "3027448274", "1061124", "3013557562", "3004944585", "3032543753", "3003828812", "3012502601", "3006638824", "3006562124", "2245304", "3013188547", "1055236", "1614993", "1064584", "1036836", "9617547", "2521877", "3016904853", "3007791573", "3012101664", "3003267729", "3006981798", "3011689956", "3014273254", "3013548553", "3007791599", "3004845555", "2246552", "3024021261", "3000268902", "2183744", "1319639", "3003300673", "3002294946", "3013176080", "3035366890", "3004060107", "3030446844", "1064514", "2030624", "1054241", "9680794", "3011137372", "2320762", "3006425876", "3004903580", "3009968482", "3009380063", "2528981", "3015207155", "3014579161", "3018064853", "3020983460", "3014279513" ], "fei_number": [ "3013403214", "3010860245", "3015453963", "1000138054", "2210968", "3002902735", "1000219637", "3005747797", "3013644499", "3002957101", "3001236905", "3003263857", "3013298431", "3003418325", "3014479313", "3014592276", "3010419931", "3011803381", "3003040625", "2648209", "3015542154", "3008114965", "1825034", "2125050", "3008912461", "3000206435", "3017196117", "2648623", "3004215117", "2183301", "3000206455", "3015330532", "3007009755", "3044819802", "3002807111", "3002692886", "3005972890", "3029901632", "3019924", "3014276972", "3014615644", "1720929", "3018094310", "3015489699", "3008879776", "3003063934", "3018052045", "3045857302", "3043226252", "3010692967", "3004111573", "3043225236", "3004161528", "3004431266", "3004365956", "3017102971", "3014272734", "3005953126", "1000274611", "3014461810", "3008868758", "1037089", "3003595343", "3007006186", "1018470", "3010041511", "3006680097", "3011085362", "1221601", "1000136478", "3003639970", "1219930", "3010452421", "2648650", "3030733800", "3003495548", "3002993297", "3011276344", "1221934", "3012494290", "3012421607", "3002807993", "3004117249", "3001124136", "3007205024", "3011683674", "1043214", "1000112968", "1721676", "2020601", "3045857207", "3010131137", "3004192065", "3038718579", "3013187142", "1000512168", "3003737899", "3045855232", "3000215273", "3003005156", "3027448274", "3013557562", "3004944585", "3032543753", "3003828812", "3012502601", "3010862763", "3006638824", "3006562124", "2245304", "3013188547", "1000112877", "3003272809", "1614993", "1036836", "2521877", "3016904853", "3007791573", "3012101664", "3003267729", "3006981798", "3011689956", "3014273254", "3013548553", "3007791599", "3004845555", "2246552", "3024021261", "3000268902", "2183744", "3003300673", "3002294946", "3013176080", "3035366890", "3004060107", "3030446844", "3006425876", "3004903580", "3009968482", "3009380063", "2528981", "3015207155", "3014579161", "3018064853", "3020983460", "3014279513" ], "device_name": "Suture, Absorbable, Synthetic, Polyglycolic Acid", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4493", "device_class": "2" } } ] }