{ "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": "176199", "product_res_number": "Z-0047-2020", "event_date_initiated": "2019-08-13", "event_date_posted": "2019-10-04", "recall_status": "Terminated", "event_date_terminated": "2021-02-11", "res_event_number": "83715", "product_code": "NEW", "k_numbers": [ "K182873" ], "product_description": "STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle\nProduct code: SXPP1B430 suture", "code_info": "Lot # LPH946 GTIN: 10705031235823", "firm_fei_number": "2210968", "recalling_firm": "Ethicon, Inc.", "address_1": "Us Highway 22 West", "city": "Somerville", "state": "NJ", "postal_code": "08876", "additional_info_contact": "Ethicon Customer Support Cente\n877-384-4266", "reason_for_recall": "The product does not meet certain internal strength testing specifications.", "root_cause_description": "Under Investigation by firm", "action": "Ethicon sent a letter on 8/30/2019. \n1. Examine your inventory quarantine the recalled product\n2. Do not open the foil pouches to conform contents\n3. Complete the Business Reply Form (BRF)confirming receipt of this notice and fax or email it to Stericycle at 888-877-7241 or Ethicon5647@stericycle.com within three (3) business days.\n4. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle\n5. Distributors are required to return unused impacted STRATAFIX\" Spiral PDS\" Plus Knotless Tissue Control Devices subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by November 30, 2019. Any non-affected product or impacted product returned after the date specified will not be replaced.\n\nIf you require any assistance with returning product, please contact Stericycle at 888-759-6910 and reference Event# 5647.\n\nIf you have additional questions regarding this recall or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 8:00 AM to 6:00 PM ET.", "product_quantity": "416 each", "distribution_pattern": "States:\nIN\nMD\nAR\nIL\nGA\nTN\nNJ\nPA\nNC\nCA\nOK\nCO\nKS\nUT\nKY\nWA\nOH\nOR\n\nOUS:\nAustralia\nHong King\nIndia\nJapan\nKorea\nSingapore\nThailand\nUnited States", "openfda": { "k_number": [ "K063680", "K080918", "K150553", "K192423", "K120827", "K191361", "K022666", "K030212", "K130191", "K080985", "K051609", "K212380", "K113004", "K100780", "K201139", "K061037", "K080680", "K030786", "K042285", "K031443", "K242571", "K232246", "K172602", "K141776", "K210871", "K242835", "K252644", "K251414", "K120284", "K240389", "K252171", "K190245", "K042075", "K261988", "K113744", "K150670", "K161737", "K162366", "K160705", "K133420", "K181582", "K013274", "K190264", "K081001", "K082097", "K143413", "K250107", "K160761", "K252047", "K250977", "K043298", "K192144", "K040004", "K073614", "K053380", "K100461", "K041048", "K123877", "K220549", "K123668", "K182873", "K071989", "K132268", "K031216", "K243897" ], "pma_number": [ "N18331" ], "registration_number": [ "", "3030733800", "3004845555", "3012494290", "3003828812", "1221601", "1054241", "3004944585", "3023274465", "3017936846", "3013403214", "2030624", "3006680097", "1000274611", "3015812758", "2528981", "3013557562", "3015138222", "3018052045", "1064584", "3016244792", "3014461810", "3014273254", "1721676", "1221934", "3016010820", "3003639970", "3008912461", "3016445763", "2650143", "3029901632", "3013376016", "3005953126", "2125050", "3010131137", "2648650", "3007895168", "3044819802", "3016904853", "3045855232", "3008868758", "3012421607", "3006638824", "3038138322", "3012502601", "3011689956", "3016560306", "1043214", "3002294946", "3027329031", "3010041511", "3006562124", "2183744", "3003267729", "2246552", "3010692967", "3004117249", "1018470", "3012438919", "3013187142", "3015289316", "3010462274", "3013354263", "3010864832", "3013589761", "3020983460", "2210968", "3014527910", "3014579161", "3007205024", "3043226252", "3014272734", "1055236", "3011137372", "1320468", "3013298431", "3017102971", "3014615644", "1614993", "3006981798", "3007791599", "3011555199", "3005972890", "9617547", "3004365956", "3013529787", "3008114965" ], "fei_number": [ "", "3030733800", "3004845555", "3012494290", "3003828812", "1221601", "3004944585", "3023274465", "3017936846", "3013403214", "3006680097", "1000274611", "3015812758", "2528981", "3013557562", "3005747797", "3015138222", "3018052045", "3016244792", "3014461810", "3014273254", "1721676", "1221934", "3016010820", "3003639970", "3008912461", "3016445763", "3029901632", "3013376016", "3005953126", "2125050", "3010131137", "2648650", "3007895168", "1000112877", "3044819802", "3016904853", "3045855232", "3008868758", "3012421607", "3003063934", "3006638824", "3038138322", "3012502601", "3011689956", "3016560306", "1043214", "3002294946", "3027329031", "3010041511", "3000206455", "3006562124", "2183744", "3003267729", "2246552", "3010692967", "3004117249", "1018470", "3012438919", "3013187142", "3015289316", "3010462274", "3013354263", "3013589761", "3020983460", "2210968", "3014527910", "3014579161", "3007205024", "3003272809", "3043226252", "3014272734", "1000112968", "2648209", "3010862763", "3013298431", "3017102971", "3014615644", "1614993", "3006981798", "3007791599", "3011555199", "3005972890", "3004365956", "3013529787", "3008114965", "3000206435" ], "device_name": "Suture, Surgical, Absorbable, Polydioxanone", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4840", "device_class": "2" } } ] }