{ "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": "66969", "product_res_number": "Z-0858-2008", "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 Wound Debridement System, Fan Spray Kit , Catalog #00-5150-475-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio", "code_info": "Lot Numbers: 60607940, 60612145, 60612148, 60613026, 60613027, 60613028, 60613029, 60613030, 60617429, 60617430, 60617431, 60617432, 60617433, 60622534, 60622535, 60622536, 60622537, 60626632, 60626633, 60626634, 60626635, 60626636, 60629997, 60629998, 60629999,  60630001, 60630002, 60633952, 60633953, 60633954, 60633955, 60640536, 60640537, 60640538, 60640539, 60640540, 60642559, 60642560, 60642561, 60642562, 60642563, 60650385, 60650386, 60650387, 60650388, 60652362, 60652363, 60652364, 60652365, 60652367, 60652368, 60652369, 60652421, 60652422, 60652424, 60652425, 60652426, 60652427, 60652429, 60661596, 60661598, 60661601, 60661604, 60661609, 60661616,  60666494, 60666495, 60693316, 60693317, 60693318,  60693319, 60693328, 60693329, 60693331, 60693332,  60693333, 60693334, 60694267, 60694268, 60694269,  60694270, 60694271, 60694272, 60698942, 60698943, 60698944, 60698945, 60698946, 60698947, 60703274, 60703276, 60703289, 60703301, 60703303, 60708431,  60708432, 60708433, 60708435, 60708437, 60709913, 60709914, 60709915, 60709916, 60709918, 60709988, 60715482, 60715484, 60715485, 60715487, 60715488, 60715490, 60723867, 60723868, 60723869, 60723870, 60723873, 60723874, 60723875, 60725490, 60725491, 60725493, 60725494, 60725496, 60733554, 60733555,  60733556, 60733557, 60733558, 60737818, 60737819,  60737820, 60737821, 60739959, 60739960, 60739961,  60739962, 60739963, 60744536, 60744537, 60744538,  60744539, 60750517, 60750520, 60750523, 60750526, 60758734, 60758735, 60758736, 60758737, 60758738, 60758739, 60758740, 60768263, 60768268, 60768269 60768270, 60768271, 60768272, 60769241, 60769242,  60769243, 60769244, 60769245, 60778396, 60778397,  60778398, 60778399, 60782132, 60782133, 60782134,  60782135, 60782136, 60784396, 60784397, 60784398,  60784401, 60784403, 60788880, 60788881, 60788882,  60788883, 60788884, 60795133, 60795140, 60795141,  60795142, 60802487, 60802488, 60802489, 60802490,  60802491, 60802492, 60804280, 60804281, and 60804282.", "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. If any recalled product is located the customer is to notify Zimmer via fax and a replacement part will be shipped to them.", "product_quantity": "24,395 kits", "distribution_pattern": "Worldwide-USA, forty-two international and one Canadian account, including countries of Singapore, Hong Kong, Lebanon, Finland, Australia, Japan, Israel, Korea, Saudi Arabia, Dubai, Denmark, Czech Republic, Guatemala, Brazil, Taiwan, China, Nicaragua, Virgin Island, Switzerland, Austria, Spain, Belgium, The Netherlands, France, Germany, Portugal, England, Sweden, India, Argentina, Italy, Chile, Thailand & Saudi Arabia", "openfda": { "k_number": [ "K253996", "K874504", "K202071", "K933742", "K820661", "K973485", "K082858", "K221504", "K210987", "K991383", "K011612", "K080779", "K143115", "K810185", "K913568", "K213616", "K253445", "K202222", "K854543", "K922083", "K926337", "K072404", "K974568", "K830386", "K790811", "K874022", "K873466", "K192349", "K060782", "K813607", "K813475", "K222804", "K972069", 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