Data from Andorra is current through November 2018. All of the data comes from Health Andorra, 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 Andorra.
Data from Andorra is current through November 2018. All of the data comes from Health Andorra, 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 Andorra.
Data from Andorra is current through November 2018. All of the data comes from Health Andorra, 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 Andorra.
Data from Andorra is current through November 2018. All of the data comes from Health Andorra, 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 Andorra.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Medtronic has become aware of instances where spine clamps have been damaged when forced open beyond their intended limits during use and will subsequently not open once attached to a patient’s spinous process. when the spine clamp is forced open beyond its intended limits, a component (captive washer) may break off. the washer could then be inadvertently left behind in a patient’s body if the breakage occurs during the procedure. if the washer is missing from the device, the spine clamp cannot be re-opened after placement on the spinous process.Medtronic has received six reports where unintended removal of spinous process occurred when attempting to detach the spine clamp. the unintended removal of spinous process can lead to damage of adjacent vertebra and cause premature degradation.
Action
Medtronic is providing an interim workaround for users via the Customer Letter. A new version of the clamps with a design mitigation will be distributed as a permanent correction once available.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Zimmer biomet is conducting a lot specific medical device recall for various polyethylene implants. the affected products are being removed due to the potential presence of elevated endotoxin levels that exceed the specification limit. the issue was discovered during routine bacterial endotoxin testing (bet). to date, no complaints related to this issue have been received.
Action
The relevant Zimmer Biomet sales representative will remove the affected product from each affected facility. There are no specific patient monitoring instructions that are recommended beyond the existing surgical follow-up protocol.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
The system 6 aseptic battery kit provides a sterile enclosure for the styker non-sterile battery. the manufacturer has identified the affected lot to have insufficient bond strength at a weld joint associated with the aseptic housing, due to an issue during manufacture. therefore, the quality of the weld may not be as effective as intended. this could lead to the separation of the top section of the housing from the bottom section. this may lead to sterility breaches, loss of surgical control, intra-operative complications and potential delays in surgery.
Action
Affected units will be replaced via the standard stock replenishment process. This action has been closed-out on 18/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
As an outcome of an investigation from a field complaint, wright medical discovered that certain claw and claw ii plates were manufactured from an incorrect raw material. the raw material specified for claw and claw ii plates is stainless steel meeting the requirements of astm f139 in a cold worked condition, however the material used meets the requirements of astm f139 stainless steel, but is in an annealed condition, which has reduced strength and increased ductility.
Action
Wright Medical is recalling affected stock from hospitals. Additionally, Wright Medical is advising surgeons that if the intended postoperative instructions are followed by the patient, the product will still perform as intended. If the patient does not follow instructions and bears weight on the plate prior to fusion the ductility of the material may increase the likelihood of malunion or non-union. Prophylactic revision surgery is not recommended. For more details, please see http://www.tga.gov.au/safety/alerts-device-claw-plates-140829.htm . This action has been closed-out on 16/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Stryker has received reports of fracture of the vertebral peek spacers when implanted with the avs aria implant inserter. according to the reported complaints, the proximal end of the implant either cracks or the tip breaks off in one fragment. there have been no reports of the broken fragment remaining in the surgical site.
Action
Stryker is advising their customers to quarantine any affected lots and will arrange for the return of any affected lots from the field.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
In the affected lots of the application instrument for sternal zipfix :· the end cap may loosen, thus reducing the tension applied to the implant. · the end cap may detach, allowing the tensioning spring to also become detached, making the instrument non-functional.If the end cap is loose, the maximum tension applied to the implant is reduced and may lead to insufficient sternal bone reduction. if the tension coil spring detaches completely from the zipfix application instrument while closing the sternum, it is possible that the spring or nut could fall into the thoracic cavity and go undetected. if the nut/spring is retained in the thoracic cavity, adverse tissue reaction may occur. no such occurrence has been reported to date.
Action
Customers are requested to immediately check their inventory to determine if the facility has any affected product and if so to quarantine those units prior to returning them to JJM for repair. This action has been closed-out on 05/09/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Baxter healthcare is issuing a recall of actifuse abx and actifuse mis system products with expiry before 29 july 2017 due to the possibility that the products may have endotoxin levels above specification criteria. in surgical procedures where there is device contact with the cerebrospinal fluid through a dural opening (iatrogenic injury), the use of a medical device with increased endotoxin levels may augment the typical inflammatory reaction to surgery and contribute to adverse health consequences. baxter has not received product-related adverse event reports that can be linked to cerebrospinal fluid exposure to increased levels of endotoxins.
Action
Users are asked to inspect their stock and to remove affected product from their facility and to contact Baxter Customer service to arrange replacements. This action has been closed-out on 05/09/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Internal testing has identified that the one-way check valve (pillow valve) included in the fms outflow tubing set and the fms intermediary tubing set may occasionally not be performing as intended. if the instructions described in the fms duo system and solo system operator's manuals are not followed, this may result in backflow of irrigation fluid into the "one day" set, and when used with affected tubing, could potentially lead to patient cross-contamination. please note that the backflow of irrigation fluid can only occur if the check valve is not working properly and the pressure line is disconnected or the tension rocker is open.
Action
Customers are asked to quarantine any affected stock and return it to JJM. Customers are also advised that when connected properly and used in accordance with the system’s Operating Manual, tubing with an affected check valve will not allow backflow of irrigation fluid into the One Day Set, and would not lead to potential patient cross-contamination. It is important to follow up with potentially affected patients per each institution’s Infectious Disease/Needle stick protocol.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
There is potential for zipfix implants to loosen if the implant is cut while the tensioning trigger is being squeezed. implants cut under tension can cause deformations in the teeth of the locking mechanism thereby compromising the integrity of the implants. the possibility exists for the zipfix implant to be compromised and loosen after implantation or during the post operative recovery period.
Action
Customers are requested to contact their local Sales Consultant to arrange for replacement with a 2nd generation Application Instrument. DePuy Synthes has confirmed that all 1st generation applicators in loan sets will be replaced with 2nd generation applicators.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
The lps lower extremity dovetail intercalary component has the potential for the female component to fracture when exposed to certain physiological loads.
Action
Johnson & Johnson Medical is not recommending prophylactic treatment in the absence of symptoms. Surgeons are recommended to review each patient’s case to determine the best treatment options, considering the patient’s weight, activity level and/or any other potential contributing factors.
If a patient presents with a fractured LPS Lower Extremity Dovetail Intercalary component with well-fixed proximal and distal stems and the surgeon determines that the LPS Lower Extremity Dovetail Intercalary component is the best treatment option, the company will make the LPS Lower Extremity Dovetail Intercalary component available. For more details, please see http://www.tga.gov.au/safety/alerts-device-limb-preservation-system-130805.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
The manufacturer has identified that there is a potential lack of the ability to thoroughly clean the instrument.
Action
The affected handle is being recalled and replaced with a new design of handle.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
The ardis system implant may break when excessive lateral forces are applied to the implant during insertion.
Action
Updated surgical technique guidance has been issued directly to surgeons to reduce the risk of off-axis loading when using the inserter.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
Multiple lots of infuse/lt cage bone graft kit is affected due to an issue with absorbable collagen sponge (acs) which is a component of the infuse/lt cage bone graft kit. the component supplier, integra lifesciences corporation has advised medtronic that a manufacturing process deviation may have resulted in some lots of absorbable collagen sponge being released and supplied to medtronic with higher levels of endotoxins than permitted by the specifications for the products. higher endotoxin levels may result in a fever in the immediate postoperative period. medtronic are not aware of any reports of patient injuries or other adverse events in connection with this issue.
Action
Medtronic is recalling the affected product and is asking clinicians through the 'hazard alert' to monitor their patients in the postoperative period in accordance with standard hospital or clinician protocol. For more details, please see http://www.tga.gov.au/safety/alerts-device-infuse-130627.htm .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notes supplémentaires dans les données
Cause
The reason for this product recall is due to a packaging issue. specifically, pin holes have been identified in a small number of pouches, which constitutes a breach of the sterile barrier.
Action
Customers to remove affected units from use and contact the Sponsor to arrange for replacement stock.
Belgian data is current through November 2018. All of the data comes from the Federal Agency for Medicines and Health Products, 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 data from the U.S. and Belgium.
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.
Notes supplémentaires dans les données
Cause
There is difficulty or inability to thread the pt hybrid glenoid post to the glenoid base. the male thread of the post may be oversized.
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.
Notes supplémentaires dans les données
Cause
During routine bioburden testing [november 10th to 20th 2017] stryker found that the levels of bioburden were higher than our internal acceptable rates. therefore stryker is initiating this voluntary recall as the sterility of the product cannot be confirmed.
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.
Notes supplémentaires dans les données
Cause
Zimmer is initiating a lot specific recall of the zimmer nexgen stemmed nonaugmentable tibial component due to the devices being proceseed through a manufacturing cleaning operation that was operating outside of the validated parameters. as a result the devices may contain residual particulate from the manufacturing process.
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.
Notes supplémentaires dans les données
Cause
Zimmer biomet is conducting a lot specific medical device field action for various polyethylene implants. the affected products are being removed due to the potential presence of elevated endotoxin levels that exceed the specification limit. the issue was discovered during routine bacterial endotoxin testing (bet). there have been no complaints received related to this issue. endotoxins (pyrogens) are substances found in certain bacteria. the fda-adopted standard for endotoxin levels is 20 eu/device. there were three samples during an approximate 6 week period that were found to exceed this level. as a result the devices manufactured during this period are being removed.
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.
Notes supplémentaires dans les données
Cause
Stryker orthopaedics is placing the otismed shape match cutting guides on hold to investigate product experience reports. the product will be on hold until the investigation is complete. at this time a product field action will be initiated to inform all surgeons registered on the otismed.Net website and all imaging centers to refrain from prescribing or performing mri or ct arthrogram for use with otismed shape match cutting guides while the investigation continues.
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.
Notes supplémentaires dans les données
Cause
Baxter corporation is issuing a recall of actifuse abx products with expiry before 29 july 2017 due to the possibility that the products may have endotoxin levels above specification criteria.