{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "151639", "product_res_number": "Z-0823-2017", "event_date_initiated": "2016-12-07", "event_date_posted": "2016-12-19", "recall_status": "Terminated", "event_date_terminated": "2017-07-17", "res_event_number": "75892", "product_code": "KRO", "k_numbers": [ "K120992" ], "product_description": "Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated\nThe product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone", "code_info": "B10635, B11820, B12776, B10636, B10638, B9866", "firm_fei_number": "3004105610", "recalling_firm": "Stanmore Implants Worldwide Ltd.", "address_1": "210 Centennial Avenue Centennial Park 210 park centennial park centennial avenue", "city": "Borehamwood", "state": "Centennial", "country": "United Kingdom", "reason_for_recall": "The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.", "root_cause_description": "Packaging", "action": "Stanmore Implants sent an Urgent Field Safety Notice dated November 25, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately check their internal inventory and quarantine all subject devices, circulate the Field Safety Notice internally to all interested/affected parties, maintain awareness of the notice internally until all required actions have been completed within their facility, inform Stanmore Implants if any of the subject devices have been distributed to other organizations, complete the attached customer response form and list of affected batches form, return the completed form and any affected devices to their S/W Representative. Customers with questions were instructed to contact their local sales representative.", "product_quantity": "15 units", "distribution_pattern": "Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA", "openfda": { "k_number": [ "K261898", "K083827", "K121029", "K191779", "K163311", "K821476", "K083779", "K122015", "K023667", "K060131", "K252303", "K223528", "K131393", "K820995", "K013031", "K223069", "K062301", "K994207", "K052685", "K190181", "K081111", "K091453", "K023087", "K251665", "K982160", "K002552", "K013385", "K101815", "K821340", "K230563", "K001957", "K151118", "K001548", "K252898", "K230416", "K150028", "K140509", "K242871", "K823420", "K130299", "K972401", "K810520", "K021489", "K120992", "K040749", "K143179", "K092138", "K151008", "K211768", "K133152", "K233980", "K013035", "K020381", "K060360", "K072367", "K041352", "K910877", "K021714", "K896048", "K070978", "K210010", "K140898", "K190100", "K031804", "K220628", "K945028", "K192798", "K211677", 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