{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 13 } }, "results": [ { "cfres_id": "218341", "product_res_number": "Z-1511-2026", "event_date_initiated": "2026-01-12", "event_date_posted": "2026-03-10", "recall_status": "Open, Classified", "res_event_number": "98342", "product_code": "KRO", "k_numbers": [ "K151008" ], "product_description": "Endo-Model SL Connection Component incl. PE-Plateau;\nItem Number: 16-2840/05;", "code_info": "Item Number: 16-2840/05;\nUDI-DI: 04026575359240;\nSerial/Lot Number: 250513/2083, 250513/2085\t, 250513/2086, 250513/2089, 250513/2090, 250513/2092, 250513/2093, 250513/2097\t, 250513/2100, 250513/2102, 250513/2104, 250513/2107, 250513/2108, 251013/3245\t, 251013/3247, 251013/3250, 251013/3251, 251013/3252, 251013/3253, 251105/0013\t, 251105/0016, 251105/0018, 251105/0020, 251105/0032, 251105/0034, 251105/0036\t, 251105/0037, 251105/0038, 251105/0039, 250513/2106, 250513/2099, 251105/0014\t, 251105/0040, 251105/0002, 250513/2087, 250513/2091, 251013/3246, 251105/0019\t, 251013/3249, 251105/0011, 251105/0012, 250513/2103, 250513/2105, 251013/3254;", "firm_fei_number": "3003386935", "recalling_firm": "Waldemar Link GmbH & Co. KG (Mfg Site)", "address_1": "Ost Str. 4-10 4-10 ost str.", "city": "Norderstedt", "country": "Germany", "additional_info_contact": "Jennifer Lubrecht\n862-477-0370", "reason_for_recall": "The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.", "root_cause_description": "Under Investigation by firm", "action": "On or about January 12, 2026 URGENT FIELD SAFETY NOTICE Product Recall letters were sent to customers. Actions to be taken:\nReview inventory to identify and quarantine any affected product. Return any unused product to the manufacturer. Follow patient management recommendations, if implanted. A custom-made replacement set can be requested. If an affected product is noticed during implantation, another plateau screw from a replacement set or different LINK knee prosthesis package can be used. If this situation occurs, a complaint form must be completed and sent to Complaint@link-ortho.com.\nThe replacement of the affected products will begin as soon as replacement products are available. Replacement will not incur any costs to you. Should you have any questions on acquiring replacements for forthcoming surgeries, please contact your local sales representative or customer service for Link products.", "product_quantity": "44 units (1 US, 43 OUS)", "distribution_pattern": "Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.", "openfda": { "k_number": [ "K161520", "K070978", "K131393", "K811105", "K230416", "K041352", "K011810", "K994207", "K242871", "K220628", "K062301", "K122015", "K821340", "K003504", "K013035", "K150028", "K130299", "K190100", "K031804", "K023087", "K151118", "K092138", "K240043", "K172347", "K001548", "K083779", "K140900", "K040749", "K013031", "K143179", "K972401", "K823115", "K010774", "K101815", "K021489", "K210010", "K083827", "K252898", "K152431", "K821476", "K211677", "K110940", "K252303", "K060131", "K820995", "K261898", "K781971", 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