Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal 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 recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Communication from ConMed Linvatec concerning the withdrawal of the PowerPro, PowerProMax and Mpower cordless devices (12/10/2009)
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal 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 recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Greatbatch Medical safety note regarding the update of the instructions for using the mallet mallet punch (catalog number T6318) and the bent cup holder (Cat. No. I-H1702HF00)
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal 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 recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Security note from MicroPort Orthopedics Inc. concerning post-operative fractures of the femoral neck element PROFEMUR Neck Var / Val 8DG Long CoCr (part number PHAC1254)
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal 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 recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Zimmer Biomet safety note regarding the withdrawal and use of certain brachial arm sets of the complete inverted shoulder system (Cat. No. 115340), manufactured before September 2011.
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.
Notas adicionales en la data
Causa
O-ring component separated from vacuum connector (blue plug).
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.
Notas adicionales en la data
Causa
Stryker has discovered that there is potential for the product to be non-sterile. it was reported that there was a potential failure during routine maintenance of the sealing machine and it is likely to have caused unsuitable cross seals on the outer pouch. it was reported that there is potential for an unsterile inner pouch of the teflon tube due to missing seal integrity.
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.
Notas adicionales en la data
Causa
The purpose of this field action is to recall all lots of part number 876-460 6860460 and 6905712 surgical instruments used with various systems. upon investigation it was determined that there is a potential for the adjustable drill stop to inadvertently adjust depths when used under powered operation. no patient injuries have been reported to date. however using an 876-460 6860460 or 6905712 adjustable drill stop could cause irreversible neurologic injury if the adjustable drill stop inadvertently adjusted and the drill penetrated through the anterior or posterior cortex of the vertebral body. if this occurred it would necessitate immediate surgical intervention repairing any damage to the surrounding vasculature/neurologic structures.
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.
Notas adicionales en la data
Causa
The screw measuring area seemed inaccurate and could cause the incorrect screw to be chosen by the medical professional. it is possible that the screw could come into contact with the lung heart muscle or an artery and this could result in a pneumothorax or bleeding.
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.
Notas adicionales en la data
Causa
Synthes (canada) ltd. was notified by their supplier synthes (usa) of six complaints reported outside the us associated with synex ii implant (central body) which fully or partially collapsed in situ after a period of six to fifteen months post operatively.
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.
Notas adicionales en la data
Causa
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.
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.
Notas adicionales en la data
Causa
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.
Notas adicionales en la data
Causa
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.
Notas adicionales en la data
Causa
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.
Notas adicionales en la data
Causa
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.
Notas adicionales en la data
Causa
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.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
hip prosthesis - Product Code LXH
Causa
The carton label reads bhr acetabular cup 60mm contained a 58mm cup.
Acción
The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
hip prosthesis - Product Code LXH
Causa
The carton label reads bhr acetabular cup 60mm contained a 58mm cup.
Acción
The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
hip prosthesis - Product Code LXH
Causa
The carton label reads bhr acetabular cup 60mm contained a 58mm cup.
Acción
The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
hip prosthesis - Product Code LXH
Causa
The carton label reads bhr acetabular cup 60mm contained a 58mm cup.
Acción
The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
hip prosthesis - Product Code LXH
Causa
The carton label reads bhr acetabular cup 60mm contained a 58mm cup.
Acción
The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Prosthesis device components - Product Code KWS
Causa
Marketed without approval: investigational devices were implanted during an ide study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the ide study; and devices implanted as "custom devices" by the manufacturer did not meet the definition of "custom devices" and were, therefore, unapproved devices.
Acción
Letters were sent via Certified Mail on 03/22/07 to the surgeons and their associated IRBs. Each letter included a list of the patients to be notified and a form letter that the surgeons could use to notify the patients. Surgeons asked to notify their patients and to provide Encore with documented evidence that patience were notified.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Stem Segments - Product Code LPH
Causa
The packaging was mislabeled: exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device.
Acción
The consignees were contacted by fax and email (dated July 21, 2006) to inform them of the recall requesting return of product
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Well Leg Holder (Arthroscopic Accessory) - Product Code NBH
Causa
The device was not manufactured to correct specification causing interference when used in conjunction with patient transfer board.
Acción
Firm notified consignees by letter and phone call on 11/1/2006. Consignees asked to return out-of-spec Well Leg Holder for a replacement.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Plate, fixation, bone - Product Code HRS
Causa
There is the potential for the bender/cutter attachment to continue heating after release of the power
button. there is potential for patient and/or staff injury if continuous heating is unrecognized.
Acción
An "Urgent: Medical Device Recall" letter dated January 8, 2010 was issued to customers via USPS Certified mail. The letter described the issue and affected product. Customers were notified to cease use of the recalled product, examine inventory and follow instructions for return to the firm as indicated in the recall letter. For questions, please call 1-800-620-7025 x 5452 or 1-610-719-5452 or contact your Synthes CMF Sales Consultant.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
hip prosthesis - Product Code LZO
Causa
The titanium plasma coating was found to have missing fragments.
Acción
The firm sent out recall notices to implanting surgeons by letter dated 03/27/2007 (via FedEx) to notify the surgeons of the issue. The hospitals and distributors were also notified of the issue and given instructions for return of the product.