Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
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It was discovered that the above part and lot numbers may have the incorrect anodized color. potential hazard: an implant with the incorrect anodized color would not cause harm to the patient. if the user identifies the nonconformity during surgery. marginal surgical delay may occur an alternate implant is located. please note that pfna. pfna—ii, dfn. & pfn na , pfna & pfna—ll blades, and pfna & pfnacil end cap extensions were manufactured correctly. with the exception of the anodized coding.
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Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
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Synthes has determined there is a potential for the adapter for colibri and small
adapter for colibri ll and small battery drive and small battery drive ii to generate excessive internal
pressure that may cause the respective products to burst. although preliminary internal tests for this failure
mode have determined this scenario is highly unlikely to occur, synthes has decided to remove these
products from the field.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
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Technique guides for the systems mentioned above describe the pedicle awls as 4.0mm for
use with screws (4.0mm — 7.0mm). these awls should be used with 5.0mm — 7.0mm
screws. this field safety notice is being issued in order to communicate changes being
made to technique guides and outer labels in order to clarify the intended use of these two
awls within these systems. there has been no change to the design or manufacture of the
pedicle awls.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
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The kirschner wire is made from cobsnibscr20m01o (mp35n) which is a cobalt based alloy
containing 35% nickel. however, the label and technique guide incorrectly indicate that the
devices are made of stainless steel.
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Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
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Through internal investigation synthes identified the potential for non-conforming helical
blades to be distributed to the field. helical blades, which are part of the tfn system, may
have one or more dimensional features out of tolerance. the potential features that may be
out of tolerance include the inner diameter of the helical blade where the guide wire passes
and the dimensional features that allow for the helical blade and insertion instrument to mate.
these non-conformances are not immediately apparent and the following is a summary of the
potential outcomes that could occur if a patient is exposed to non-conforming product.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
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There are potential harms associated with the distal aiming arm not being manufactured in
accordance to the specifications.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 Singapore.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
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Please note that these products were originally recalled in 2013. unfortunately, due to an
error, they were re-distributed. we apologize for this inconvenience.
synthes is initiating a voluntary recall of the below mentioned lots of the cmf matriledface,
mandible and orthognathic due to the possibility that clips on the screws may be
incorrectly etched with the wrong length.
each screw is packaged in a “clip” that has a laser etch corresponding to the length of the screw.
it has been reported that the etch on the clip does not correspond to the length of the screw.
there have been instances in which the screw was longer than the specified etch, as well as the
screw being shorter than the specified etch. please note: there has not been any adverse event to
patient reported with use of these screws, in all cases of complaints received, there was no patient
mm
it is not likely that the presence of a screw that is packaged in the incorrect clip holder will result in
a serious adverse event. there is a remote probability that a medically reversible or transient
adverse health event will result due to a screw being packaged in the incorrect clip holder.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
The guide wire 0 3.2 mm. length 400 mm included an incorrect raw material listed on the label.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
There is the potential that the tfna nails received before march 31, 2015 from the affected
lots were assembled with a locking mechanism too close to the top of the nail.
the locking mechanism could:
. prevent the connecting screw from fully tightening the insertion handle to the nail
resulting in a loose or toggling nail in the insertion handle, or
. cause the bottom of the connecting screw to tighten against the top of the locking
mechanism preventing advancement of the locking mechanism.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
It was discovered that the specified lots listed above of the drill sleeve may not couple with
the protection sleeve, part number 356.705 due to the potential for interference between
these two devices.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
The entire depuy synthes radial head prosthesis system is affected by this removal, however it is the radial
stern that has the possibility of loosening post—operatively at the stem bone interface based on the currently
available data, we believe the cause to be multifactorial (including possible product characteristics, operative and
patient factors), but we have not been able to fully characterize these factors. consequently, we have not been
able at this time to issue further instructions to surgeons that might lead to a reduction in issue rate and have
decided to remove the depuy synthes radial head prosthesis stem from the global market.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Precautionary statements are being added to the “reamer/ lrrigator / aspirator (ria) surgical technique guide". it was reported that the ria drive shaft, tube assembly, and reamer head have the potential to break when incorrectly assembled or used improperly.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
There is a lack of proof of material biocompatiiity for the insert for dhs/dcs lmpactor no.
338.280. single (part number 338260) used in the existing product (lots specified)
(polyamide 6.6 with 20% carbon fiber reinforcement. tecamid 66 cf 20). no compatibility
testing has ever been completed by synthes for this material and no evidence was found that
it has been completed by other entities.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Synthes has determined there is a potential the affected lots of the synream flexible shaft (352.040
and 352.044) may have been manufactured with a non-symmetric hexagonal coupling which may
result in the reamer shaft not fitting into the reamer heads.
the synream flexible shafts are intended for use as an optional reaming step in intramedullary nailing
systems. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Synthes gmbh is initiating a medical device removal of the impactor for pfna blade. the pfna
impactor is part of the pfna and pfna-ii systems used for treating high energy fractures in younger
patients and low energy fractures in older patients. it is used to insert the pfna blade, by applying
gentle blows with a hammer to the distal end of the impactor.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Through a complaint investigation, it was discovered that the affected lots of the extraction
screw could break or disassemble from the instrument. this may interfere with removal of
the pfna and pfna-ll blade from the patient.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Kimal received a complaint from one party that the above product was inconsistent when sealing the bag. after an internal inspection of the stored specimens, we identified some instances where the pouch was not sealed in the corner where it normally opens, meaning that the product is no longer sterile. we kindly ask you to review your stock of the above mentioned product and batch numbers. if you find that the bag is not sealed, remove the product in question from your stock and discard it. tell kimal how many products you have discarded and you will receive free replacement items. the photos below show a seal error and acceptable seal:.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Druiba kimal plc has received complaints from clients stating. that the echogenic introductory needle 186, adapted to these accessories, in a small number of cases during use. reported problems occurred during catheter insertion, aspiration of blood into the syringe to confirm correct needle placement, or during infusion. during the aspiration process a crack in the plunger was observed and occasionally air bubbles were observed in the syringe. leakage was observed during the infusion.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 Singapore.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
We would like to inform you about a potential issue we have identified with the contour®
diabetes app (version 1.2.0 or lower) when it is synchronizing data with the contour
cloud. there is the potential for an isolated, very rare situation to occur where some of the
data stored in the contour cloud may be incomplete.
please note that this situation will only affect users using the same contour cloud account
for the app on more than one mobile device (smartphone or tablet). the data on the
contour® next/plus one meter and on the mobile device (“primary device”) that directly
receives data from the meter are not affected, and will always show the correct and
complete information including glucose values and meal markers. a health care professional
report can still be generated and transmitted from the primary device (phone or tablet).
if you have used the contour® diabetes app prior to version 1.2.0 in switzerland or poland
this may be the second letter that you have received regarding this issue. version 1.2.0 did
not completely resolve the issue.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
We would like to inform you about an issue we have identified with the latest version of
glucofacts deluxe (3.10.07) when it is receiving insulin and carbohydrate values from the
contour®next/plus one meter that were manually entered into the contour® diabetes
app.
please note that this issue only affects users of glucofacts deluxe version 3.10.07 who are
using it with the contour®next/plus one meter and have entered insulin and
carbohydrate values in the contour® diabetes app. if you are using a
contour®next/plus one meter without the app or using any other contour® meter,
you are not affected and can use glucofacts deluxe without any limitations. blood glucose
measurements transferred from all contour® meters, including contour®next/plus
one, are also unaffected. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Three false negative results were reported by a customer when testing three different
patient samples with insti hiv-1/hiv-2 antibody test kit from lot 1512ba033.
all customers that received the insti hiv-1/hiv-2 antibody test kit lot 1512ba033 were
initially advised (by means of field safety notice ai002.17.N, dated 19 january 2017) to
quarantine any kits from this lot remaining in their inventory.
biolytical laboratories inc. the manufacturer of insti hiv-1/hiv-2 antibody test conducted
a thorough investigation using the insti kits from lot 1512ba033 that were retained at the
manufacturer’s facility and sample kits returned by the complainant. sera samples of the
patients that tested false negative with insti kits from lot 1512ba033 were also used by
biolytical laboratories inc. to conduct the investigation. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
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The on/off functionality in the lcsu 4 is controlled by electronic components. one of
these components might be damaged. the damage occurs over time when the unit is
connected to a power source (battery or external power source), but is not related to
frequency of use.
a damaged component will result in failure of the on/off functionality: the lcsu 4
cannot be turned off, and it may turn on by itself. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
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In order to ensure that your laerdal suction unit (lsu) is in compliance with iso 10079-11, one of the
following actions described as option 1 and option 2 below must be taken.
please read the below information carefully and report back to laerdal on the attached customer
response form within three weeks.
option 1: where the lsu is not stored or installed in cold temperatures -
re-label the lsu with revised conditions at which the lsu can be stored and
installed before operation
if this is the case, you may continue to use the lsu without any changes to the unit. in order to
inform end-users of the lsu about the limitation in operating conditions, we ask you to re-label your
lsu with the revised operating conditions 12 °c to 40 °c (54 °f to 104 °f).
to re-label your lsu, a new operating conditions label provided by laerdal medical is required.
when labelled according to these instructions, the lsu complies with iso 10079-1 without need of
any further actions.
if you decide to re-label your lsu with revised operating conditions – please complete section 1 of the
customer response form.
in the response form, we ask you to specify the number of lsu units that are currently in use, so that
laerdal medical may provide you with a suitable number of labels. .