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
Smith & nephew inc. has initiated a voluntary field safety corrective action/recall of the ceramic hip prostheses. the current hip prostheses ifus do not provide adequate instruction on the revision surgeries due to ceramic failure. the ifu does not provide the detailed instructions that if a hip prostheses revision is required due to a fractured ceramic component revisions shall only be performed using a ceramic femoral ball head in order to prevent any potential undue wear of the revision components.
Model Catalog: 75001939 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75001938 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017194 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017202 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017201 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017200 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017199 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017198 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017197 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75017196 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75001947 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 75001946 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71500471 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71500470 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71500469 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71500468 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog:
제품 설명
SL-PLUS MIA STANDARD;POLARCUP SHELL CEMENTED - S&N;POLARSTEM STANDARD TI-PLASMA/HA SAP #;SL-PLUS MIA LATERAL;SLR-PLUS LATERAL FEMORAL STEMS (S+N);POLARCUP PE X-LINKED INSERT;529750 SL-PLUS LATERAL CEMENTLESS FEMORAL HIP STEM;SL-PLUS INTEGRATION-PLUS MIA S