{ "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": "29087", "product_res_number": "Z-0107-04", "event_date_initiated": "2003-08-01", "event_date_posted": "2003-11-13", "recall_status": "Terminated", "event_date_terminated": "2004-12-12", "res_event_number": "27053", "product_code": "KRO", "product_description": "17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. \n\nPart of the ''RT/RT Modular'' total knee replacement.", "code_info": "No code information applies.", "firm_fei_number": "3001237832", "recalling_firm": "Plus Orthopedics", "address_1": "6055 Lusk Blvd", "city": "San Diego", "state": "CA", "postal_code": "92121", "additional_info_contact": "Niel Delaney\n888-741-7587 Ext. 2511", "reason_for_recall": "Plastic insert over articular surface of knee joint replacement may become dislodged.", "root_cause_description": "Other", "action": "Firm telephoned each distributor to ensure that devices were not used in upcoming surgeries on 8/1 or 8/26/2003.", "product_quantity": "35", "distribution_pattern": "AZ, ID, TX CTdistributors.", "openfda": { "k_number": [ "K230563", "K040749", "K242871", "K021260", "K972401", "K140509", "K211677", "K163311", "K223069", "K031480", "K101815", "K110940", "K133152", "K011810", "K013031", "K013340", "K140900", "K821476", "K013035", "K121029", "K261898", "K003504", "K223528", "K781971", "K062301", "K211768", "K820995", "K031804", "K041352", "K120992", "K081111", "K161520", "K013385", "K821340", "K910877", "K151008", "K811105", "K151118", "K220628", "K945028", "K002552", "K190181", "K810520", "K190100", "K896048", "K023667", "K010774", "K051479", "K021489", "K020381", "K252898", "K083779", "K072367", "K140898", "K251665", "K091453", 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