Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Zimmer biomet is conducting a lot specific medical device field action for vanguard knee system ps open box femoral components due to inadequate line clearance at the supplier between april 5 2016 and september 1 2016. as a result the packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). it is highly detectable at the point of use that the device was incorrectly labelled. the estimated rate of occurrence is 0.001% (<1 in 1000 products).
Model Catalog: 183133 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183132 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183130 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183128 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183126 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183124 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183102 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183113 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183112 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183110 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183108 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183106 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183104 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 183122 (Lot serial: >100 LOT NUMBERS CONTACT MFR)
제품 설명
VANGUARD TOTAL KNEE SYSTEM-PS OPEN BOX FEMORAL COMPONENTS
“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.