{ "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": "42416", "product_res_number": "Z-0085-06", "event_date_initiated": "2005-09-24", "event_date_posted": "2005-10-21", "recall_status": "Terminated", "event_date_terminated": "2005-12-14", "res_event_number": "33771", "product_code": "GAR", "product_description": "Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units.", "code_info": "Lot number M732780", "firm_fei_number": "2522801", "recalling_firm": "Surgical Specialties Corp", "address_1": "100 Dennis Dr", "city": "Reading", "state": "PA", "postal_code": "19606-3776", "additional_info_contact": "Dianna Shurr\n610-404-1000 Ext. 2229", "reason_for_recall": "mislabeled as double armed straight needle actually single armed straight needle", "root_cause_description": "Other", "action": "On 9/24/05, the recalling firm issued notifications to their customers via fax informing them of the problem and the need to return any remaining product to the recalling firm.", "product_quantity": "27 boxes", "distribution_pattern": "The product was shipped to hospitals in IL, KY, NC, NE, OR, UT, and VA. The product was also shipped to distributors in FL, KY, PA, TN, and VA.", "openfda": { "k_number": [ "K212888", "K261484", "K943223", "K960327", "K931914", "K032160", "K994176", "K001173", "K943222", "K993970", "K042367", "K903029", "K981322", "K161633", "K023028", "K943216", "K031531", "K060471", "K041510", "K905379", "K030177", "K932037", "K920510", "K060528", "K912429", "K930586", "K003000", "K926587", "K052900", "K151165", "K192420", "K904052", "K930943", "K931612", "K913102", "K212603", "K024090", "K926168", "K081366", "K931613", "K123034", "K905286", "K000539", "K993998", "K152795", "K904931", "K903177", "K922530", "K981582", "K042284", "K220980", "K930517", "K052482", "K990090", "K053637", "K900531", "K020146" ], "pma_number": [ "N85060", "N85316", "N83511", "N80838" ], "registration_number": [ "3030733800", "3004845555", "3012494290", "3018094310", "2244478", "1221601", "9611484", "3017196117", "1054241", "3004944585", "2648623", "3012342459", "3013403214", "2030624", "1000274611", "2320762", "3013557562", "3007791573", "3018052045", "1064584", "2245304", "3004111573", "3014461810", "3012026312", "2032098", "1221051", "1054811", "3011560638", "3014273254", "3004192065", "1721676", "2521877", "9614747", "3003639970", "3012101664", "3008912461", "1061124", "3016426842", "3029901632", "1219930", "3007074233", "1111225", "3005953126", "3010452421", "3010131137", "2523835", "3029835193", "2648650", "3017636737", "3038718579", "3014592276", "3044819802", "1064017", "3016904853", "3008483449", "9616088", "3045855232", "3003915875", "1930126", "1058584", "2085887", "1423537", "3012421607", "3006638824", "3012502601", "3013849323", "3011689956", "3015183635", "3029754081", "1043214", "3002692886", "1037089", "3010041511", "3030446844", "3013002341", "1066741", "3006562124", "3003267729", "2246552", "3010692967", "1017294", "3004117249", "2183301", "3014117096", "1018470", "3013187142", "3032543753", "3004215117", "1062741", "3010864832", "3022766613", "3020983460", "2210968", "3014579161", "3007205024", "3014276972", "9612501", "1055236", "3011137372", "3015330532", "3010162973", "3006425876", "3009513193", "9611459", "3013548553", "1226146", "3013298431", "3017102971", "3014615644", "3006981798", "3007791599", "1064514", "3045857302", "1062668", "9680794", "3004365956", "9710098", "3004060107" ], "fei_number": [ "1000219637", "3030733800", "3004845555", "3012494290", "3018094310", "1221601", "3001738911", "3017196117", "3004944585", "2648623", "3012342459", "3013403214", "1000274611", "3013557562", "3005747797", "3007791573", "3018052045", "2245304", "3004111573", "3002957101", "3014461810", "3012026312", "1221051", "3011560638", "3014273254", "3004192065", "1721676", "2521877", "3003639970", "3012101664", "3008912461", "3003005156", "3016426842", "3000302153", "3000190635", "3029901632", "1219930", "3007074233", "1111225", "3005953126", "3003040625", "3010452421", "3010131137", "2523835", "3029835193", "2648650", "3017636737", "3038718579", "1000112877", "3014592276", "3044819802", "3016904853", "3008483449", "3045855232", "3003915875", "1000135614", "1930126", "3001639746", "3012421607", "3003063934", "3006638824", "3002807993", "3003495548", "3012502601", "3002807390", "3002902735", "3013849323", "3011689956", "3001236905", "3015183635", "3029754081", "1043214", "3002692886", "1037089", "3010041511", "3030446844", "3013002341", "1000512168", "3006562124", "3003267729", "2246552", "3010692967", "1000114185", "1017294", "3004117249", "2183301", "3014117096", "1018470", "3013187142", "3032543753", "3004215117", "3003058448", "3004161528", "3022766613", "3020983460", "2210968", "3014579161", "3007205024", "3014276972", "1000112968", "3015330532", "3010862763", "3006425876", "3009513193", "3013548553", "3013298431", "3002807041", "3017102971", "3014615644", "3006981798", "3007791599", "3003737899", "3045857302", "3002680121", "1000136269", "3004365956", "3004060107", "3000206435" ], "device_name": "Suture, Nonabsorbable, Synthetic, Polyamide", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5020", "device_class": "2" } } ] }