{ "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": "197225", "product_res_number": "Z-0480-2023", "event_date_initiated": "2022-11-16", "event_date_posted": "2022-12-14", "recall_status": "Open, Classified", "res_event_number": "91192", "product_code": "NEW", "product_description": "PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1\nProduct Code: Z340H\n\nFor use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery", "code_info": "UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box)\nLot: SCMSHK\n\nExp. Date: February 28, 2027", "firm_fei_number": "2210968", "recalling_firm": "Ethicon, Inc.", "address_1": "Us Highway 22 West", "city": "Somerville", "state": "NJ", "postal_code": "08876", "additional_info_contact": "SAME\n908-218-0707", "reason_for_recall": "knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage", "root_cause_description": "Under Investigation by firm", "action": "Ethicon notified the four impacted countries via \"URGENT: MEDICAL DEVICE RECALL (REMOVAL)\" beginning Nov 16, 2022. Letter states reason for recall, health risk and actions to be taken. The customers were instructed to:\nExamine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s).\n2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed.\n3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating.\n4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and return to Ethicon, Inc. within three (3) business days. Please return the BRF even if you do not have product subject to this recall.\n5. Keep this notice visibly posted for awareness until all product subject to this recall has been returned. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records.\n6. Customers are required to return unused PDS\" II products subject to this recall that are in inventory immediately. To receive credit reimbursement, customers must return product subject to this recall to Ethicon, Inc. Any non-affected product and any product returned after the date specified will not receive credit reimbursement.\n\nIf you have any questions, call 908-218-0707.", "product_quantity": "7,560 eaches", "distribution_pattern": "International (OUS) only: Canada, Japan, Australia and New Zealand", "openfda": { "k_number": [ "K250107", "K120284", "K080680", "K080918", "K051609", "K220549", "K251414", "K081001", "K192144", "K250977", "K040004", "K133420", "K190264", "K061037", "K210871", "K252644", "K030212", "K053380", "K082097", "K150670", "K120827", "K242571", "K013274", "K100780", "K192423", "K212380", "K160761", "K073614", "K123668", "K181582", "K132268", "K160705", "K190245", "K042075", "K240389", "K031216", "K261988", "K161737", "K022666", "K071989", "K232246", "K063680", "K141776", "K242835", "K113744", "K113004", "K123877", "K162366", "K243897", "K201139", "K043298", "K030786", "K130191", "K031443", "K150553", "K041048", "K100461", "K080985", "K191361", "K252047", "K252171", "K042285", "K172602", "K143413", "K182873" ], "pma_number": [ "N18331" ], "registration_number": [ "3013403214", "2210968", "3013298431", "3008114965", "3016445763", "2125050", "3008912461", "2650143", "3044819802", "3005972890", "3010864832", "3029901632", "3014615644", "3013589761", "3018052045", "3043226252", "3010692967", "3007895168", "3004365956", "3017102971", "3014272734", "3005953126", "3015812758", "1000274611", "3014461810", "3008868758", "3027329031", "3013376016", "1018470", "3010041511", "3006680097", "1221601", "3003639970", "3015138222", "2648650", "3015289316", "3030733800", "3017936846", "3038138322", "1221934", "3012494290", "3012421607", "3004117249", "1320468", "3012438919", "3014527910", "3013529787", "3007205024", "1043214", "1721676", "3010131137", "3013354263", "3013187142", "3045855232", "3013557562", "3004944585", "3030141376", "3003828812", "3016010820", "3012502601", "3006638824", "3006562124", "1055236", "1614993", "1064584", "9617547", "3016904853", "3003267729", "3010462274", "3006981798", "3011689956", "3014273254", "3007791599", "3004845555", "3016560306", "2246552", "3011555199", "2183744", "3002294946", "3023274465", "2030624", "1054241", "3011137372", "2528981", "3014579161", "3020983460", "3016244792" ], "fei_number": [ "3013403214", "2210968", "3005747797", "3013298431", "2648209", "3008114965", "3016445763", "2125050", "3008912461", "3000206435", "3000206455", "3044819802", "3005972890", "3029901632", "3014615644", "3013589761", "3003063934", "3018052045", "3043226252", "3010692967", "3007895168", "3004365956", "3017102971", "3014272734", "3005953126", "3015812758", "1000274611", "3014461810", "3008868758", "3027329031", "3013376016", "1018470", "3010041511", "3006680097", "1221601", "3003639970", "3015138222", "2648650", "3015289316", "3030733800", "3017936846", "3038138322", "1221934", "3012494290", "3012421607", "3004117249", "3012438919", "3014527910", "3013529787", "3007205024", "1043214", "1000112968", "1721676", "3010131137", "3013354263", "3013187142", "3045855232", "3013557562", "3004944585", "3030141376", "3003828812", "3016010820", "3012502601", "3010862763", "3006638824", "3006562124", "1000112877", "3003272809", "1614993", "3016904853", "3003267729", "3010462274", "3006981798", "3011689956", "3014273254", "3007791599", "3004845555", "3016560306", "2246552", "3011555199", "2183744", "3002294946", "3023274465", "2528981", "3014579161", "3020983460", "3016244792" ], "device_name": "Suture, Surgical, Absorbable, Polydioxanone", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4840", "device_class": "2" } } ] }