Device Recall Pulsavac

  • Model / Serial
    Lot Numbers: 60650389, 60693321, 60708442, 60778376, 60788853, and 60809433.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Orthopaedic Surgical Products, 200 W Ohio Ave, Dover OH 44622-9642
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

9 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers: 60613025, 60617428, 60622532, 60626631, 60629996, 60633951, 60640534, 60650384, 60652419, 60656841, 60661592, 60661594, 60666491, 60666492, 60671448,  60671449, 60676102, 60693310, 60693311, 60693314, 60693315, 60693326, 60693327, 60694265, 60694266, 60698941, 60703269, 60709912, 60715481, 60723866,  60725488, 60733552, 60733553, 60737816, 60737817, 60739957, 60739958, 60744533, 60744534, 60750514, 60750515, and 60758733
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    Pulsavac, Plus Wound Debridement System, Component Kit, Catalog # 00-5150-420-00,10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
  • Model / Serial
    Lot Numbers: 60622533, 60642558, 60654878, 60656842, 60693312, and 60725489
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    Pulsavac Plus Wound Debridement System, Fan Spray Kit , Catalog #00-5150-475-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
  • Model / Serial
    Lot Numbers: 60626637, 60652433, 60671457, 60693320, 60698948, 60708439, 60715492, and 60725499
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    Pulsavac Fan Spray Kit ,Catalog #00-5150-475-01; 1kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
  • Model / Serial
    Lot Numbers: 60612157, 60612160, 60613031, 60613032, 60617434, 60617435, 60622538, 60626638, 60630003, 60630004, 60633956, 60633957, 60633958, 60640541, 60640542, 60642564, 60642565, 60642566, 60650390, 60650391, 60652435, 60656852, 60656853, 60656854, 60661621, 60661622, 60661623, 60666504, 60666506, 60693313, 60693322,  60693323, 60693336, 60693338, 60693340, 60694275,  60694276, 60694278, 60698949, 60703306, 60708444, 60709920, 60715493, 60723876, 60725500, 60733559, 60733560, 60737822, 60737823, 60739964, 60739965, 60744540, 60744542, 60750527, 60750528, 60758741,  60758742, 60768273, 60768274, 60769247, 60769248, 60778401, 60778402, 60782137, 60782138, 60784405 60784407, 60788885, 60788886,and 60795145.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    Pulsavac Plus Wound Debridement System, Hip Kit, Catalog #00-5150-482-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
  • Manufacturer
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