German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: greatbatch medical standard offset cup impactor
the united states food and drug administration (fda) has issued a medical device safety alert concerning standard offset cup impactor manufactured by greatbatch medical. the affected device was manufactured from january 2004 through january 2013 and distributed from january 2004 through december 2013.
the manufacturer has identified through internal sterility assurance level validation testing that a sterility assurance level of 10-6 is not achieved on the standard offset cup impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current instructions for use provided with the device. the manufacturer has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.
greatbatch has developed new sterilization recommendations that meet acceptable sterility assurance levels (aami st79 standard). customers who have the affected product should immediately begin utilizing the new sterilization instructions.
for details, please refer to the following fda websites:
http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1119-2014&w=03122014&lang=eng
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm388928.Htm
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm389005.Htm
http://www.Fda.Gov/safety/recalls/ucm388883.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 13 march 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: depuy lps (limb preservation system) lower extremity dovetail intercalary component
it has come to our attention that the medical device manufacturer, depuy orthopaedics, inc. has initiated a field safety corrective action concerning its lps (limb preservation system) lower extremity dovetail intercalary component. the affected part number is 1987-19-055.
according to the manufacturer, the affected product has the potential for fracture of the female component when exposed to certain physiological loads. bench testing simulating loads under normal walking conditions demonstrated that patients over approximately 200 lbs. (90 kg) are at higher risk and that increasing weight may pose increasing risk. however, common activities such as stair ascent and descent and rising from chairs may exert forces higher than those under normal walking conditions. other factors such as the patient’s musculature, activity level, and overall health should also be considered.
the possible clinical implications related to this issue, which could only occur if the product should fracture, include:
poor mechanics and loss of function
pain
dislocation: the separation of the male component from the female component
adverse tissue reaction if the broken piece of the female component were to completely break free and cause irritation to the surrounding tissue.
damage to bone in areas that are important for revision surgery. surgeon may be unable to conduct revision surgery due to lack of sufficient bone stock, potentially resulting in amputation if no other therapeutic options remain available.
the clinical implications above may lead to revision surgery.
depuy provides the following advice to the affected customers:
customers are advised to stop further distribution or use of the affected products immediately for use in primary surgery.
depuy is not recommending prophylactic revision in the absence of symptoms. however, surgeons are encouraged to communicate with patients who received these implants as deemed appropriate (considering weight and activity level).
depuy recommends that surgeons 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.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 19 july 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: zimmer m/l taper with kinectiv technology femoral stems and necks
the united states food and drug administration (fda) has issued medical device safety alerts concerning m/l taper with kinectiv technology femoral stems and necks, manufactured by zimmer.
the manufacturer has initiated a voluntary recall of 64 lots (752 implants total) of m/l taper with kinectiv femoral stems and modular necks due to higher than allowed cytotoxicity levels found with the product.
the manufacturer found a process monitoring failure that led to higher than expected amounts of manufacturing residues left on the devices. these residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. use of these products may require the need for a revision surgery to replace the affected implant.
according to the local supplier, the affected products are not distributed in hong kong.
for details, please refer to the fda websites:
http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1699-2015&w=06172015&lang=eng
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm452012.Htm
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm451936.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 june 2015.
Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 Sweden.
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.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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.
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
Acción
Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
Immediately locate and remove the affected product.
Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product.
Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756.
For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
Causa
This recall was initiated due to a customer complaint which reported that while peeling off the tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device.
Acción
Biomet sent a "FIELD SAFETY NOTICE" dated April 21, 2011, to all affected accounts. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product, locate and remove from inventory and quarantine pending return to their Bioment distributor.
Customers were also instructed to complete and return the attached "Fax Back Response Form" to their local Biomet distributor.
For questions customers should contact their local Biomet Contact.