{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183794", "product_res_number": "Z-0172-2021", "event_date_initiated": "2020-09-09", "event_date_created": "2020-10-21", "recall_status": "Open, Classified", "res_event_number": "86462", "product_code": "MAI", "k_numbers": [ "K151105" ], "product_description": "HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor\nProduct Number: 72203708", "code_info": "Batch Numbers: 2014002 2016196 2017814 2020051 2021388 2023272 2024724 2026266 2024759 2025289 2027469 2030955 2031023 2033400 2035501 2036291 2038328 2039263 2048404 2049924 2051020 2053921 2056432 2057402", "firm_fei_number": "3003604053", "recalling_firm": "Smith & Nephew, Inc.", "address_1": "150 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1031", "reason_for_recall": "Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch", "root_cause_description": "Equipment maintenance", "action": "Smith & Nephew issued Urgent Medical Device Recall letter (R-2020-19) FSN on September 9, 2020 via email or overnight mail to customers that received affected products. Letter states reason for recall, health risk, and action to take:\nRequired Actions:\n1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately.\na. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete.\nb. Include the customers account number and name in the table below.\n2. If you have no product to return, please put an X in the appropriate location below.\n3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below.\n4. Complete the remainder of the form, sign and send to FieldActions@smith-nephew.com.\nPlease Note even if you have no product to return, this form must be completed, signed and returned.\n5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number.\nIf you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.", "product_quantity": "263,874 (total)", "distribution_pattern": "Nationwide\nForeign:\nAE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY,\nCZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK,\nHU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL,\nPR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA", "openfda": { "k_number": [ "K120589", "K012334", "K181809", "K983435", "K001378", "K252022", "K973849", "K243467", "K993373", "K082810", "K222263", "K112249", "K003970", "K952471", "K203495", "K990340", "K993115", "K173240", "K180361", "K102982", "K992567", "K011495", "K130917", "K973281", "K202806", "K192484", "K140855", "K252946", "K994161", "K091844", "K212912", "K993074", "K955768", "K103831", "K240288", "K173859", "K180768", "K993453", "K180960", "K003227", "K961789", "K993339", "K232513", 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"3015231789" ], "device_name": "Fastener, Fixation, Biodegradable, Soft Tissue", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3030", "device_class": "2" } } ] }