{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215662", "product_res_number": "Z-2605-2025", "event_date_initiated": "2025-08-15", "event_date_posted": "2025-09-19", "recall_status": "Open, Classified", "res_event_number": "97471", "product_code": "NEW", "k_numbers": [ "K192144" ], "product_description": "STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.", "code_info": "Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.", "firm_fei_number": "3007791599", "recalling_firm": "ETHICON, LLC", "address_1": "475 Calle C Ste 401 475 Calle C", "address_2": "Ste 401", "city": "Guaynabo", "state": "PR", "postal_code": "00969-4292", "additional_info_contact": "1877-384-4266", "reason_for_recall": "Potential for barb non-engagement.", "root_cause_description": "Under Investigation by firm", "action": "On August 15, 2025, Ethicon, LLC issued an \" Urgent Medical Device Recall (Removal)\" Notification. Ethicon asked consignees to take the following actions: \n\n1. Examine stock and quarantine affected product.\n2. Share notification with all personnel. \n3. Complete the response form and and fax 888-202-5865 or email ethicon7924@sedgwick.com\n4. Return all unused product. \n5. Keep this notice visibly posed for awareness. \n6. If assistance is needed, please contact Sedgwick at 888-266-7913 and reference Event # 7924.", "product_quantity": "516 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AR, AZ, CA, IL, IN, KS, MA, MD, MI, MO, MN, NC, NH, NM, TX, VA, WA, WI and the countries of Singapore and Malaysia.", "openfda": { "k_number": [ "K040004", "K113004", "K061037", "K120827", "K252171", "K141776", "K080918", "K261988", "K071989", "K150553", "K080985", "K250977", "K143413", "K190264", "K210871", "K073614", "K031216", "K123668", "K162366", "K160705", "K041048", "K120284", "K160761", "K232246", "K123877", "K022666", "K030212", "K242571", "K252644", "K250107", "K053380", "K031443", "K242835", "K252047", "K051609", "K042075", "K063680", "K201139", "K133420", "K172602", "K181582", "K130191", "K190245", "K182873", "K043298", "K100461", "K080680", "K113744", "K132268", "K192423", "K220549", "K251414", "K253879", "K240389", "K191361", "K082097", "K243897", "K100780", "K081001", "K161737", "K042285", "K030786", "K150670", "K192144", "K212380", "K013274" ], "pma_number": [ "N18331" ], "device_name": "Suture, Surgical, Absorbable, Polydioxanone", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4840", "device_class": "2", "registration_number": [ "3014527910", "3016010820", "3013187142", "3016904853", "3006981798", "3012494290", "2125050", "3013529787", "1721676", "3014615644", "2210968", "3016445763", "1614993", "3013298431", "3012421607", "3005953126", "3012502601", "9617547", "3004944585", "3008114965", "3003828812", "3014273254", "3030733800", "2648650", "3015289316", "3016244792", "2183744", "3011555199", "3014579161", "3010462274", "3015812758", "1054241", "3043226252", "3045855232", "3011689956", "3014272734", "2528981", "2650143", "3013403214", "3007791599", "3006680097", "1000274611", "1055236", "3010692967", "3023274465", "3020983460", "3005972890", "1043214", "3044819802", "3017936846", "3013376016", "3013354263", "3013557562", "3027329031", "1221934", "3010131137", "3008868758", "3038138322", "3029901632", "3006638824", "3004845555", "3004117249", "3030141376", "3004365956", "3002294946", "2246552", "3015138222", "3010041511", "3012438919", "3014461810", "3016560306", "3003267729", "1064584", "1221601", "3011137372", "3018052045", "3013589761", "3007895168", "3008912461", "3007205024", "1018470", "1320468", "3003639970", "2030624", "3017102971", "3010864832", "3006562124" ], "fei_number": [ "3014527910", "3016010820", "3013187142", "3016904853", "3006981798", "3012494290", "2125050", "3013529787", "1721676", "3003063934", "3014615644", "2210968", "3010862763", "3016445763", "1614993", "3013298431", "3012421607", "3005953126", "3012502601", "3004944585", "3008114965", "3003828812", "3014273254", "3030733800", "2648650", "3015289316", "3016244792", "2183744", "3011555199", "3005747797", "3014579161", "3010462274", "3015812758", "3043226252", "3045855232", "3011689956", "3014272734", "2528981", "1000112968", "3013403214", "3007791599", "3006680097", "1000274611", "3003272809", "3010692967", "3000206435", "3023274465", "3020983460", "3005972890", "1043214", "3044819802", "3017936846", "3013376016", "3013354263", "3013557562", "3000206455", "3027329031", "1221934", "3010131137", "3008868758", "3038138322", "3029901632", "2648209", "3006638824", "3004845555", "3004117249", "3030141376", "3004365956", "3002294946", "2246552", "3015138222", "3010041511", "3012438919", "3014461810", "3016560306", "3003267729", "1000112877", "1221601", "3018052045", "3013589761", "3007895168", "3008912461", "3007205024", "1018470", "3003639970", "3017102971", "3006562124" ] } } ] }