{ "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": "169776", "product_res_number": "Z-0728-2019", "event_date_initiated": "2018-12-04", "event_date_created": "2019-01-11", "recall_status": "Terminated", "event_date_terminated": "2020-06-05", "res_event_number": "81762", "product_code": "MEH", "k_numbers": [ "K171273" ], "product_description": "BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02\n\nThe LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.", "code_info": "Lot# 1707121", "firm_fei_number": "3003386935", "recalling_firm": "Waldemar Link GmbH & Co. KG (Mfg Site)", "address_1": "Oststr. 4-10 4-10 oststr.", "city": "Norderstedt", "country": "Germany", "additional_info_contact": "Len Tokish\n201-694-7331", "reason_for_recall": "The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.", "root_cause_description": "Employee error", "action": "The firm, LinkBio Corp., Sent an \"URGENT MEDICAL DEVICE RECALL\" letter dated 12/4/2018 to its customers. The letter describes the product, problem and actions to be taken. The customers are instructed to do the following:\nPlease identify your total inventory for this product.\n1) Immediately cease use and segregate the above described product.\n2) Complete the enclosed Consignee Reply Form, even if you have no inventory.\n3) Return the above product and a copy of the Consignee Reply Form using Federal Express Account # 007183879 to:\nLinkBio Corporation\n101 Roundhill Drive\nRockaway, NJ 07446\nRecall Return Authorization #: R-2018-02\n\nEnsure that all users of the above products within your organization and other relevant persons have been notified of this safety information. If you have transferred the products to third parties, please pass on a copy of this information or notify the contact person indicated below.\n\nShould you have any questions or require assistance, please contact 1-973-625-1333 ext. 116 between 8:00 am - 5:30 pm (M-F) EST or email: nikhil@linkbio.com at any time.", "product_quantity": "30", "distribution_pattern": "US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.", "openfda": { "k_number": [ "K023302", "K113320", "K910156", "K993943", "K040680", "K910755", "K951671", "K211703", "K971422", "K242315", "K905781", "K912452", "K896047", "K912654", "K913916", "K020963", "K112091", "K944836", "K993768", "K915350", "K080584", "K081044", "K983382", "K251166", "K181778", "K992815", "K990666", "K955305", "K171273", "K980070", "K112556", "K020615", "K241690", "K951291", "K121627", "K092406", "K000262", "K934729", "K023102", "K946234", "K922621", "K020572", "K013676", "K993077", "K032641", "K162303", "K150855", "K162732", 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