The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Withdrawal from the market of certain batches of the product "Helmet of the Glenosphere Reverse Trabecular MetalTM", manufactured by Zimmer, Inc., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Updating of surgical techniques due to the risk of fracture of the upper and lower components of the construction of the Tibial Provisional Tibial Articular Surface (TASP) of the Zimmer Persona System, manufactured by Zimmer, Inc. EEU
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Removal from the market of certain batches of bone screws "Trilogy" of 6.5mm x 35mm and 6.5x25mm, manufactured by Zimmer, Inc. USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Removal from the market of batch 56570612 of the bracket bracket of the cemented tibial drill 15.7 + 30mm Persona, manufactured by Zimmer, Inc. USA, when engraved on the wrong drill number bracket.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Removal from the market of all batches of the 4.5 mm cortical screws, listed as compatible with the M / DN system, manufactured by Zimmer, Inc. USA, because they are not compatible with this system
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Removal from the market of certain batches of the "Femoral impactor heads", catalog number 00-5901-032-00, manufactured by Zimmer, Inc., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Removal from the market of all batches of certain references of Guide Needles, manufactured by Zimmer, Inc. USA, labeled with an expiration date of 10 years.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Removal from the market of certain references and lots of Sterile Metal Trabecular implants in aluminum bags, manufactured by Zimmer, Inc., USA, due to the possibility of the bags presenting tears or holes that could compromise their sterility.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Removal from the market of certain references and batches of shoulder, knee and hip implants, manufactured by Zimmer, Inc. USA, and Zimmer GmbH, Switzerland, due to the possibility of adhesion of the packing bag of low density polyethylene (LDPE) ) to the surface of the implants.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Possibility of rupture and detachment of the tongues in certain lots of the "Trabecular Metal Reverse Glenosphere Helmets", manufactured by Zimmer, Inc., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Update of the surgical technique due to the possible decoupling or difficulty to couple the Glenosphere and the Base Plate of the Zimmer Trabecular Metal Reverse Shoulder System, manufactured by Zimmer, Ltd. USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Possibility of adhesion of the packaging bag of low density polyethylene (LDPE) to the highly polished surface of certain implants manufactured by Zimmer, Inc., USA (for Warsaw products) and Zimmer GmbH, Switzerland (for Winterthur products).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The ingredient that gives hydrophilic properties to this impression material was left out of the formulation. the two different trade names and corresponding lot numbers are listed above.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
An abbott investigation has identified that the ict serum calibrator lots above may generate lower than expected potassium quality control (qc) and patient results.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Recently, during inspection of incoming components from a supplier, 3m discovered a valve with incorrectly labeled “input” and “output” orientation.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Upon a voluntary inspection of the manufacturing process, a potential impairment of the sterility of the above mentioned products were detected.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Programming translation error may lead to temperature readout lower than actual patient temperature.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Programming translation error may lead to temperature readout lower than actual patient temperature.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR , Swissmedic
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Samples tested using architect free t3 or architect total t3 assays may show depressed results due to reagent carryover when testing on board with the assays specified in table 1 (see attached fsn) .