{ "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": "66968", "product_res_number": "Z-0857-2008", "event_date_initiated": "2007-12-18", "event_date_posted": "2008-03-06", "recall_status": "Terminated", "event_date_terminated": "2012-05-03", "res_event_number": "46206", "product_code": "FQH", "product_description": "Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio", "code_info": "Lot Numbers: 60622533, 60642558, 60654878, 60656842, 60693312, and 60725489", "firm_fei_number": "1526350", "recalling_firm": "Zimmer Orthopaedic Surgical Products", "address_1": "200 W Ohio Ave", "city": "Dover", "state": "OH", "postal_code": "44622-9642", "additional_info_contact": "Joyce Elkins\n330-364-9483", "reason_for_recall": "Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.", "root_cause_description": "Other", "action": "Zimmer notified their customers via an Urgent Device Recall letter dated January 8, 2008. The letter requests each customers to inventory their stock. 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