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.
Notas adicionales en la data
Causa
Medtronic have identified that when an ap-vs interval measures 100-109ms during a short, nightly device check, a single reset is generated. this reset produces a non-programmable, wireless carealert, but does not alter device therapy. if the device experiences more than five resets due to this timing sequence between in-clinic device interrogations, a full reset (sometimes referred to as a power on reset) will occur. by design, a full reset automatically reverts device operation to rv-only pacing at vvi/65 until the next programmer session is conducted – at which time the full reset condition can be cleared, and the device can be reprogrammed to its prior settings.
Acción
Medtronic are advising that a software update, Application SW040 Version 8.1, is available for installation onto all CareLink Model 2090 and Encore programmers to eliminate this issue. Once installed, an in-clinic device interrogation will update the patient's device automatically to prevent this timing interaction from generating a reset.
Surgeons are advised:
- To contact their local Medtronic Representative to schedule installation of the updated Percepta CRT-P Application Software onto Medtronic 2090 and Encore Programmers.
- For a patient who has been implanted with a Percepta CRT-P device, consider scheduling an in-clinic device interrogation as soon as possible following installation of the updated application software, for the patient’s device to receive the automatic update.
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.
Notas adicionales en la data
Causa
Philips has received reports of instances where after a continuous operation of more than one and a half days, the image on the flexvision large screen monitor froze for about 15 seconds. thereafter, the system restored itself and was fully operational again.This is only applicable to allura systems with a flexvision large screen monitor. all other monitors to the system are not affected.To date, philips is not aware of any injuries that may have occurred due to this issue.
Acción
Philips is advising this issue will be resolved in a software upgrade, expected to be available by the second half 2018. Users will be contacted by Philips when the software is available for installation.
In the interim, users are advised to restart the system at least once per day to prevent occurrence of this issue.
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.
Notas adicionales en la data
Causa
Getinge have identified a possible water leakage on limited washer disinfectors of model type wd15. if this issue occurs, both an acoustic and visual alarm ("a03 over flow co" on the machines display) will be present. this leakage may take place during operation in the last part of the cleaning and disinfection cycle. the leaking water has not been processed through the machine and from investigations it does not make contact with critical electrical components of the washer.If the issue is left unattended, there can be a leakage of cold water out from the water supply to the machine (up to 2 l/min). if users do not respond to the alarm, there may be a significant amount of water on the floor which may result in a person falling and acquiring an injury. there is also a risk for property damage from the water leak.To date, no injuries have been reported as a result of this issue.
Acción
Getinge are advising they are investigating this issue and will provide a solution as soon as it becomes available.
In the interim, users may continue to use the washer, provided that the machine is not left unattended.
Users should react to device alarms immediately.
If an alarm *A03 OVER FLOW CO* is activated, users are advised to do the following;
1. Switch off the main switch;
2. Close shut off valves in the water supply lines; and
3. Contact a service technician.
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.
Notas adicionales en la data
Causa
Ambu australia has received reports regarding the potential for the ‘cushion seal to separate from the mask’. to date, there have been no adverse health consequences or medical interventions reported due to this issue.
Acción
AMBU is advising customers to inspect stock and quarantine all AMBU UltraSeal II Anaesthetic Masks. AMBU will arrange collection of all the affected masks
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.
Notas adicionales en la data
Causa
Nxstage has identified a potential risk of electrical fire, in the event fluid leaks into the power receptacle on the back of the express fluid warmer. this risk exists at any time whilst the warmer is plugged in. nxstage has received 7 reports of smoke, sparks or flames coming from the express fluid warmer since 2016. there have been no adverse health consequences or medical interventions reported as a result of this issue.Given the occurrence of these incidents, the instructions for use (ifu) are being updated with a warning about fluid bags and fluid near the warmer, along with instructions on how to minimise this risk.
Acción
NxStage, through Regional Health Care Group have taken the decision to
replace the Instructions for Use with an updated IFU.
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.
Notas adicionales en la data
Causa
Philips have identified that the first time an operator selects a new procedure type during a single examination, the shutter position resets to the open position for the new procedure type. if the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
Acción
Philips is advising this issue will be resolved in a software update, expected to be available in the second half of 2018. Philips will notify users when this software update is available.
Until a software revision that corrects this issue becomes available, users should verify that the desired shutter position is set when performing the run after the first time the procedure type is changed during a single examination. This can be accomplished by first selecting a different procedure and then reselect the original procedure on the Xper Module or on the Data Monitor.
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.
Notas adicionales en la data
Causa
Device technologies has been notified by the manufacturer, symmetry surgical, of a product complaint regarding a monopolar pencil and cord. the reporting site observed some anomalies in the packaging seal resulting from the package’s contents having migrated near or within the seal area. this condition increases the risk of the seal’s integrity being compromised. testing indicated that the defect is introduced during the packaging operation and will not result from shipping or normal handling conditions.
Acción
Device Technologies (DTA) is advising customers product is acceptable for use if it is visually confirmed that the package's contents do not interfere with the packaging seal and the seal is intact.
Users are advised to either:
- Inspect all affected product in accordance with the inspection instructions outlined in the Customer Letter. Product that does not meet acceptance criteria should be shipped back to DTA for credit. If users are uncertain if product is acceptable it is advised to return the item; OR
- Ship stock held of the Olsen Single Use Electrocautery Forceps/Pencils/Cords back to DTA for credit.
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.
Notas adicionales en la data
Causa
Baxter healthcare have identified the potential for a leak to occur at the tube to cap junction of the in-line blood set with filter (mmc2433). preliminary investigation has shown that this issue is due to the combination of cap dimension variability, especially on lower limit, and insertion depth of the cap into the tube on the lower side.To date, no complaints have been received as a result of this issue.
Acción
Baxter is advising customers to identify and quarantine affected product from their facility. Baxter will arrange return of product from impacted users.
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.
Notas adicionales en la data
Causa
Zimmer biomet, on behalf of lmt surgical, has been made aware via complaint investigation that unexpected lumen may be present in the interface of the handle with the metal chisel. products exhibiting this issue would not be able to be reprocessed with the validated reprocessing cycles.
Acción
Zimmer Biomet is advising customers to return all affected product.
This item is no longer supplied in Australia.
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.
Notas adicionales en la data
Causa
Zimmer biomet has identified that specific serial numbers of dermatome an may have a loose control bar which could compromise the ability to control the thickness of the graft. the affected devices could also potentially have a loose width plate that if undetected, could result in an imperfect, yet still usable graft.
Acción
Zimmer Biomet is advising customers to immediately inspect stock and quarantine affected product. A Zimmer sales rep will contact sites to arrange return and replacement with an unaffected batch.
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.
Notas adicionales en la data
Causa
Smith & nephew have identified that the product visionaire lightweight alignment rod is oversized, preventing mating with the visionaire alignment connector.
Acción
Once the recall acknowledgement has been received and there is product to be retrieved, a Smith & Nephew Representative will go to the hospital to retrieve the affected items are provide replacement products
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.
Notas adicionales en la data
Causa
Ge healthcare has identified that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. if the incorrect version is loaded on the system, the images can be flipped left/right and/or there can be patient data mismatch.
Acción
GE Healthcare are advising they will inspect all affected systems and ensure the proper software version is installed. GE Healthcare will check systems remotely (on-line) where possible, and will visit sites if a remote check is not possible.
GE Healthcare will advise users after the software version has been inspected and if any correction is needed. If a correction is needed, a service representative will contact users to arrange for this correction.
Users may refer to the information in the Customer Letter to check their system software version. If an impacted system is identified, users are advised to contact their GE representative immediately
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.
Notas adicionales en la data
Causa
Philips have identified that when the operator or a bystander touches the area of the inner part of the vertical sliding column (on which the tube arm moves up or down), without paying attention of the tube arm movement, the operator's fingers can be pinched.
Acción
Philips are advising that they will install a new label on affected systems. A Philips Service Engineer will contact customers when the Field Action Kit is available to be implemented.
In the interim, customers may continue to use their systems, provided they follow the Instructions for Use which outlines that users keep all body parts and clothing free of the equipment to avoid getting caught or trapped within the moving components.
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.
Notas adicionales en la data
Causa
B. braun has been identified that some of the items in specific batches have damaged packaging which may affect the sterility of the products. no specific monitoring of patients is recommended at this time.To date, there have been no reports of any adverse patient outcome which could be associated with this potential sterility issue.
Acción
B. Braun is requesting customers:
1. Identify, quarantine and return affected devices;
2. Do not use affected devices anymore;
3. Patients with affected devices in use should be monitored carefully;
4. Inform the responsible personnel in the relevant facilities; and
5. Confirm receipt of the correspondence as per the instructions given in the Customer Letter.
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.
Notas adicionales en la data
Causa
Ortho clinical diagnostics australia has identified the potential for positively biased sample results to occur when using certain vitros na+ slides. results for serum/plasma and urine samples obtained using impacted vitros na+ slides may be positively biased and quality control fluids may be outside of the expected ranges. the amount of bias in the vitros na+ method is dependent upon multiple sources of variability.Two separate issues have been identified:- vitros na+ slides, gens 8 & 13: positively biased urine sample results; and - vitros na+ slides, gens 13, 14, 16, 17 & 18: positively biased serum or plasma sample results.
Acción
Ortho Clinical Diagnostics is advising:
For VITROS Na+ Slides, GENs 8 & 13:
- Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 8 & 13, regardless of sample type used for testing.
For VITROS Na+ Slides, GENs 14, 16, 17 & 18:
- Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 14, 16, 17 & 18, regardless of sample type used for testing.
- It is acceptable to continue to use remaining slides until your replacement order arrives provided both of the following criteria are met:
1. Calibration is successful and Quality Control results are within acceptable limits; and
2. Distribution of normal results for serum or plasma samples are centred within the established reference interval for the laboratory.
If at any time during use of remaining slides, any of the above criteria are no longer met, discontinue use and notify the requesting physician for all previously reported Na+ results that are likely affected where applicable.
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.
Notas adicionales en la data
Causa
Stryker australia has discovered that two (2) lots of tritanium-pl cages, part number 48950066 (lot # a8am) and part number 48954066 (lot # a8t2), were shipped and sold to australia without market release approval. the tritanium-pl cage product family has been registered and approved in australia. however, the specific part numbers 48950066 and 48954066 were not registered in australia.
Acción
Stryker Australia is requesting recipients of the letter to confirm whether they possess any affected stock and to inform any parties who may have received affected stock and to inform Stryker of this using the supplied response forms.
A hazard alert is also being issued.
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.
Notas adicionales en la data
Causa
Emergo have identified the potential for the tethered plug on the hub inadvertently opening after closure. the tethered plug not staying closed in the feeding tube hub may result in a leak of nutrition from the feeding tube. as described in the instructions for use (ifu) provided with the product, sterile water should be the only liquid that would leak from the feeding tube when the user flushes the tube before and after use. to date, no adverse events related to this issue have been reported to neomed.
Acción
Emergo is requesting that users examine their inventory for product subject to this recall and quarantine all affecetd stock until a return can be facilitated as per the instructions given in the Customer Letter.
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.
Notas adicionales en la data
Causa
It has been identified by emergo that some raystation/rayplan users have commissioned machines with erroneous beam profile correction parameters. these parameters affect the dose calculated in corners of large or off-axis fields. to the best of our knowledge, the issue has not caused any patient mistreatment.
Acción
Emergo is requesting that users:
Always validate the beam model for all clinically relevant fields, including, but not limited to, large and off-axis fields, before the system is used to create clinical treatment plans.
- Carefully review all beam model parameters before commissioning.
- Be aware that the Beam profile correction values may need to be adjusted in order to correctly model the primary collimator that limits the dose in the corners of large or off-axis fields.
- Review any existing photon beam models to ensure that the actions above have been properly performed.
Please educate physics staff about these user responsibilities.
Inspect your product and identify all installed units with the above software version number(s), then confirm that you have read and understood this notice by replying to the notification email.
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.
Notas adicionales en la data
Causa
Bio-rad have observed that the values for blood and ketones may gradually decrease, and values for ph may gradually increase over the shelf life of affected product lots. this issue is not expected to impact patient results.
Acción
Bio-Rad is advising users that the package insert has been updated to specify the changing values for these analytes.
Laboratory means and acceptable ranges may need to be re-established for Blood, Ketones and pH during the shelf life of the product.
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.
Notas adicionales en la data
Causa
Stryker has discovered that specific lots of the mako rio system irrigation clip have the potential to fracture. the rio system irrigation clip is a sterile disposable, used to direct saline flow for the burring tool during a mako partial knee surgery. in the event of a break in the mako rio system irrigation clip, potential hazards of a fractured device and/or foreign object (inert particulate left in wound) may occur.
Acción
Stryker is advising customers to inspect inventory and quarantine affected product, Stryker will contact customers to arrange return of affected product.
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.
Notas adicionales en la data
Causa
The bd alaris infusion pump administration sets require priming prior to use as described in the directions for use (dfu). bd has identified a potential issue with the bd alaris infusion pump administration sets manufactured during january 2017 through march 2018. the issue pertains to the back check valve and the ability to prime the administration sets. the manufacturer has determined the root causes leading to this issue are associated with: 1. excessive solvent used to connect the tubing to the back check valve leading to an obstruction of the fluid path, thus preventing the priming of the set. 2. a higher “cracking” pressure of the back check valve.To date, no injuries have been reported as a result of this issue.
Acción
CareFusion is advising that users can continue to use the product.
When a set cannot be appropriately primed, users may be able to increase the pressure by gently squeezing the IV bag following these steps:
1. If no drops are observed, gently squeeze the bag at the fluid level with one hand once. Observe if set is able to prime.
2. If no drops are observed repeat this up to 3 times.
3. If this method is not effective discard and replace the administration set.
4. Consider having additional administration sets available in clinical areas where high risk infusions are administered.
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.
Notas adicionales en la data
Causa
A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. to date, no injury has been reported to ge as a result of this issue.
Acción
GE is advising they will be in contact with users to arrnage for impacted products to be corrected.
In the interim, users may continue to use the system by following the existing Operator Manual Safety Information for proper patient padding and observation during scanning.
If a brown discolouration is seen on the inner surface of the patient bore, or if a burning smell is noticed, please contact the local GE Service Representative.
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.
Notas adicionales en la data
Causa
Bio-rad have identified that certain lots of mrsaselect ii agar may have abnormal colouration and growth of non-characteristic mrsa colonies.If plates were exposed to light but none defects have been detected before use, then mrsa colonies may appear white to yellow instead of the pink characteristic colour, or the growth may be delayed. as a result, there is a risk of misinterpretation of the result.
Acción
Bio-Rad is advising:
- For the references and batches of affected product, do not expose the boxes more than 4 hours to light during the intermediate storage steps, including returning at room temperature, and during incubation until the reading step.
- Do not use a suspicious colour agar.
- As recommended in the package insert, if in doubt, confirm the identification of colonies by coagulase test or Pastorex Staph Plus.
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.
Notas adicionales en la data
Causa
Ge has been made aware when multiple carescape monitor b650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. the monitor restart will not be completed until the network issue has been corrected. loss of overall monitoring for a prolonged time may lead to a delay in detection of permanent or irreversible impairment or life-threatening changes in the condition of the patient.To date, ge has not received reports of injury as a result of the reboot process.
Acción
GE Healthcare is advising that they will in contact with users to arrange correction of affected products.
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.
Notas adicionales en la data
Causa
The current packaging and ifu indicate a five-year shelf life. during long-term product testing, it was discovered that after a three-year term, there is a potential for the external packaging (sterile barrier) to become compromised. such compromised packaging results in the loss of the vacuum seal allowing for contamination of the inside peel pouch. a breach of the outer peel pouch has only been observed with packages at shelf life end and after excessive transportation testing.To date, medtronic have not received any complaints as a result of this issue.
Acción
Stryker is advising customers to quarantine affected stock to prevent further use. Stryker representatives will contact customers to help coordinate the return of any affected product.
In the event this device has been recently implanted, surgeons are advised to monitor for signs of infection as per their normal processes.