{ "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": "124856", "product_res_number": "Z-0833-2014", "event_date_initiated": "2013-12-05", "event_date_posted": "2014-01-27", "recall_status": "Terminated", "event_date_terminated": "2015-04-13", "res_event_number": "67171", "product_code": "KCT", "k_numbers": [ "K120117" ], "product_description": "Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distributed under the following names:\r\nSmall\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8732, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8733, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8734, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8735, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8744, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8745, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8746, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8747, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8748, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Small 4 Latch, REF 50-8950, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Small 4 Latch, REF 50-8951, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Green Small 4 Latch, REF 50-8952, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Blue Small 4 Latch, REF 50-8953, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Red Small 4 Latch, REF 50-8954, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Black Small 4 Latch, REF 50-8955, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nMedium\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8736, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8737, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8738, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8749, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8750, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8751, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Medium 4 Latch, REF 50-8956, 445mm x 279mm, QTY: 1, Symmetry Surgical, Inc., \r\n\r\nSymmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Medium 4 Latch, REF 50-8957, 445mm x 279mm, QTY: 1,", "code_info": "all lots", "firm_fei_number": "3007208013", "recalling_firm": "Symmetry Medical/SSI", "address_1": "3034 Owen Dr", "city": "Antioch", "state": "TN", "postal_code": "37013-2413", "additional_info_contact": "Ajey Atre \n800-251-3000", "reason_for_recall": "The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier.", "root_cause_description": "Process control", "action": "The firm notified their consignees of the recall by letter and email on 12/02/2013 instructing customers not to use the containers until further notice from Symmetry Surgical.", "product_quantity": "2,991 units", "distribution_pattern": "Worldwide Distribution - US (Nationwide) and PR; and Internationally to: Italy, Australia, Saudi Arabia, UK, China, Canada, Germany, New Zealand, Colombia, Korea, and Chile.", "openfda": { "k_number": [ "K092682", "K932086", "K760320", "K142937", "K230680", "K192670", "K782144", "K962545", "K141616", "K162815", "K200632", "K110500", 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"K810469", "K160912", "K203492", "K223662", "K243425", "K042062", "K830961", "K893802", "K203198", "K241050", "K222005", "K831588", "K940807", "K240898", "K210923", "K143579", "K061033", "K142519", "K933560", "K210836", "K092745", "K040223", "K112087", "K152745", "K182052", "K973440", "K070765", "K891214", "K142529", "K945055", "K973981", "K953068", "K181845", "K201412", "K152241", "K133015", "K072563", "K143729", "K101653", "K191566", "K162063", "K932056", "K250029", "K242762", "K231291", "K173391", "K172850", "K190665", "K112090", "K192487", "K251614", "K980065", "K973827", "K962600", "K182032", "K102122", "K171692", "K152951", "K231144", "K231604", "K891215", "K860528", "K142109", "K160574", "K220791", "K221492", "K253791", "K170939", "K152743", "K171713", "K243128", "K152014", "K222514", "K212068", "K120474", "K181933", "K163598", "K170640", "K173642", "K182084", "K151347", "K182865", "K953776", "K222328", "K993764", "K130720" ], "device_name": "Sterilization Wrap Containers, Trays, Cassettes & Other Accessories", "medical_specialty_description": "General Hospital", "regulation_number": "880.6850", "device_class": "2", "registration_number": [ "3010393565", "9610617", "3026612481", "3010707607", "3015224777", "3008959420", "3015336263", "3006948427", "1058584", "3014663814", "9617111", "1416980", "3007487007", "3008791019", "3015392401", "3006113180", "1417592", "8043971", "3003418325", "3017820152", "3005900820", "3023155873", "3007389669", "3042940623", "3014553709", "3010041430", "3008864603", "3005409899", "9610612", "1828288", "3009973505", "3003604053", "9611274", "3011824442", "3016607092", "3024788684", "1423662", "3013247477", "3003990090", "8040233", "3011050570", "3005706667", "3038549074", "3015181082", "3009417901", "2132732", "3011577940", "3004153240", "3010684280", "3006540014", "3008114965", "3010363542", "3010157088", "1828464", "1720499", "1833920", "3009959868", "3013868968", "3019878714", "3010202439", "3014421917", "3008693672", 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