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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원인
Synthes is initiating a recall on all lots of the synthes spiral blade associated with the modular blade plate system due to a potential for an out of specification star grind teeth of the spiral plate. the potential of insufficient depth of the spiral blade star grind teeth could lead to loosening of the coupling screw. this may present a potential risk to the patient including loss of reduction construct failure and need for additional surgical intervention.
Model Catalog: 02.122.600 (Lot serial: ALL LOTS); Model Catalog: 02.122.601 (Lot serial: ALL LOTS); Model Catalog: 02.122.571 (Lot serial: ALL LOTS); Model Catalog: 02.122.586 (Lot serial: ALL LOTS); Model Catalog: 02.122.606 (Lot serial: ALL LOTS); Model Catalog: 02.122.605 (Lot serial: ALL LOTS); Model Catalog: 02.122.585 (Lot serial: ALL LOTS); Model Catalog: 02.122.570 (Lot serial: ALL LOTS); Model Catalog: 02.122.551 (Lot serial: ALL LOTS); Model Catalog: 02.122.615 (Lot serial: ALL LOTS); Model Catalog: 02.122.580 (Lot serial: ALL LOTS); Model Catalog: 02.122.581 (Lot serial: ALL LOTS); Model Catalog: 02.122.616 (Lot serial: ALL LOTS); Model Catalog: 02.122.575 (Lot serial: ALL LOTS); Model Catalog: 02.122.576 (Lot serial: ALL LOTS); Model Catalog: 02.122.620 (Lot serial: ALL LOTS); Model Catalog: 02.122.621 (Lot serial: ALL LOTS); Model Catalog: 02.122.565 (Lot serial: ALL LOTS); Model Catalog: 02.122.561 (Lot serial: ALL LOTS); Model Catalog: 02.122.560 (Lot serial: ALL LOTS); Model Catalog: 02.122.5
제품 설명
SYNTHES MODULAR BLADE PLATE SYSTEM 100MM SPIRAL BLADE