{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183301", "product_res_number": "Z-2999-2020", "event_date_initiated": "2020-08-17", "event_date_created": "2020-09-22", "recall_status": "Open, Classified", "res_event_number": "86290", "product_code": "HXK", "k_numbers": [ "K163142" ], "product_description": "Speed Stitch Needle Cassette", "code_info": "Model: OM-8850 Lot Numbers: 2018434, 2018934, 2019558, 2019559, 2019929, 2019930, 2020931, 2022111, 2022641, 2030008, 2032212, 2033815, 2037604, 2036941, 2038701, 2039699, 2040500, 2042295, 2044957, 2047483, 2048575, 2051239 & 2032526", "firm_fei_number": "3010813691", "recalling_firm": "ArthroCare Corporation", "address_1": "7000 W William Cannon Dr Bldg 1 7000 W William Cannon Dr", "address_2": "Bldg 1", "city": "Austin", "state": "TX", "postal_code": "78735-8509", "additional_info_contact": "Gary M. Smith\n901-399-1970", "reason_for_recall": "Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.", "root_cause_description": "Mixed-up of materials/components", "action": "On August 17,2020 the firm notified all its consignees via letter of the field action. They provided the following instructions:\nPlease inspect your inventory and locate any devices from the listed product and batch numbers, and quarantine them immediately.\n\" If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out.\nIf you have no product to return, please put an X in the appropriate location.\nIf you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes.\nComplete the remainder of the form, sign and send to FieldActions@smith-nephew.com or fax to +1-901-566-7975.", "product_quantity": "6,366 needles", "distribution_pattern": "Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT,DB,FL,GA, HI, IA, ID, IL, IN, KS, KY, MA,MD,ME,MI,MN,MO,MS,MT, NC,ND, NE, NJ, NSW, NV,NY, OH,OK, OR, PA,SC, TN,TX, UT, VA, WA, WI, WV.\nInternational Distribution: AE, AU, CH, DE, FI, FR, GB, HK, IE, PA, PR, PT, RU, SG, and ZA", "openfda": { "k_number": [ "K772388", 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"3007334784", "3018094310", "3035708926", "3002291143", "3008902714", "3005809810", "3010288346", "3004111573", "3002378832", "3029082594", "3016965929", "1000115048", "3004216008", "3000178338", "3014201171", "3012267976", "3002806315", "1000518604", "1828464", "1000525271", "1825034", "3016096142", "3002631673", "3002807395", "3007389672", "3003963832", "1526439", "2027754", "3008618183", "1000555370", "3003120897", "3043355002", "3013846070", "3012656745", "3003431869", "3010235355", "3006487092", "3008392711", "3002902735" ], "device_name": "Holder, Needle; Orthopedic", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4540", "device_class": "1" } } ] }