Stryker Knee Replacement Recall
Getting knee replacement surgery done through Stryker breakthrough product might prove to be lethal for some. After serious complications have been developed in some patients, the firm has decided to recall its products back immediately. Though the FDA lauds the proactive effort from Stryker in protecting the lives of people without thinking about profits, the same laments the recklessness of the firm in offering enough protection for the people when needed the most. Considering the fact that a number of surgeons across the nation are seriously contemplating and performing the operations, it might be just that the matter could be out of hands already.
Some Factors That May Cause Stryker Knee Replacement Recall
Stryker is a famous company that produces a lot of knee replacement devices. There are many people who use the devices from this company. It is very popular for its ShapeMatch Cutting Guide that can be used to help all patients with knee problems. This product is commonly used by many doctors for treating all patients with knee problems. However, there are some issues that may occur with this device. In 2013, FDA notified all healthcare professionals to recall this device because of its defects. There are some reasons behind the Stryker knee replacement recall. You have to read these reasons, so you can know why you have to avoid using this device.
Some Reasons Behind the Stryker Knee Replacement Recall
1. This product doesn’t have FDA approval
This is the first reason why this device is recalled from the market. This product doesn’t have FDA approval for being used in many hospitals and other clinics. Because of that reason, the FDA is not able to check and control the safety of this product. As all we know, the Food and Drug Administration (FDA) is responsible for all medical devices or products that are distributed to public. It is important for all medical device manufacturers to have FDA approval before they can sell their medical devices or products to other health practitioners.
2. Not accurate result
The FDA believes that this device can give wrong result when it is used by most doctors or surgeons. There is a software defect that can result in wide cutting range during the procedure. This is another reason behind the Stryker knee replacement recall. This inaccurate design can lead to wrong displayed parameters, including angle of cut, depth of resection, and some other parameters. It is very important to have the right parameter during the knee surgical procedure. Therefore, this product is not recommended for all surgeons or medical care experts.
3. Can lead to some health problems
This is another reason why there was Stryker knee replacement recall. This product can result in serious health consequences, such as fracture, joint instability, revision surgery, chronic pain, mobility limitation, and some other health problems. The FDA received about 44 reports of incidents related with the use of Stryker ShapeMatch Cutting Guide. There are many other problems that may be caused by this device. It has some defects that can be dangerous for human being. Because of these disadvantages, this product is prohibited for being used by any medical practitioners.
They are some good reasons why FDA had the Stryker knee replacement recall for this product. In 2013, a product notification was released to all agencies, branches, surgeons, or risk managers at certain hospitals. This product has not been available since 2013. All medical care experts are encouraged to report any adverse events or other side effects that may be caused by these products. It is important for all surgeons to find another alternative that can be used to guide them in their surgery. There are some other products that can be used to guide all surgeons in performing their surgery comp
Stryker Knee Replacement Recall After Successful Marketing Of The Product
After being touted as the best thing to happen for knee replacement patients, the use of Stryker products has proved to be a bane for them in several ways. Firstly, it has been observed that numerous problems have been developed in those people gradually who have undergone the surgery already. Secondly, the class I status awarded to the product might be just that many people might lose their life as well. Understanding the intensity of the problem in an effective manner, the firm has issued serious guidelines to all the surgeons and hospitals to not to use the product anymore in the best interests of the lives of patients concerned.
Impact Of Stryker Knee Replacement Recall Upon Knee Replacement Surgeons
Several advancements have been made by the surgeons performing knee replacements by taking advantage of the available technology. The process involves cutting of the bone to the extent where the product fits perfectly. Adverse lapse of the technological features has resulted in the consideration of calling back the product without any information divulged any further. Checking out various features in this regard without checking actual facts might be a bold step. However, there is enough evidence with the FDA already that why any serious action could not be taken.
Major Developments Before the Stryker Knee Replacement Recall Took Place
At a time when the knee replacement surgeries involving Stryker products have been seen as the best options for people even with hopeless situations, the Stryker Knee Replacement Recall is something that is unexpected for sure. Getting the best treatment on time is what looks forward to, but no one would ever like to risk their lives for sure. Perhaps, this is exactly what happened with Stryker due to which expecting normal situation back in the concerned people has become a distant reality.
Possible Issues With Stryker Knee Replacement Recall In The Future
Firstly, those people who have undergone the surgeries might be at serious risk of losing their life. Secondly, others who went through the ordeal could take an effective action against the firm by filing a lawsuit. Additionally, there will be scores of people from different medical backgrounds along with experienced surgeons and medical representatives who will be pressing in for a better explanation about the future. Dealing with all such sensitively complex situations without hurting anyone is not an easy thing to contain for sure.
Crucial Information About Stryker Knee Replacement Recall Products
Knee replacement surgeries for athletes and others have proved to be a boon in recent times due to the advanced in modern medical technologies. However, there are certain instances such as the Stryker Knee Replacement Recall that make things hugely complicated to understand for sure. Getting along with the situation without going through any major health issues is something that everyone looks forward to during such hopeless situations. It has been observed that some patients have developed serious complications even after the surgery has went all the way fine. The whole blame has to be put on the cutting guides available from shapematch to assist surgeons further.
All You Need To Know In Detail About Stryker Knee Replacement Recall
At a time when the knee replacement surgery is seen as the only hope for people with adverse knee problems, it cannot be understood how the knee recalls from Stryker could ever take place. It all began with serious side effects cropping up in those who have already undergone the surgery. Instead of betting the personal health condition with perfect functioning of the knee, the entire matter got worsened much to everyone’s surprise. It is only then that Stryker started taking a serious note of the concluding happenings that it started instructing surgeons not to perform the surgeries anymore.
Portage Inspection Is the Key For Stryker Knee Replacement Recall
There is solid proof available with the FDA that the firm immediately started issuing warnings to the concerned hospitals and surgeons who might get along with the surgeries. As far as Stryker is concerned, there is much to show in the form of Portage inspection that holds the crucial details about how the surgery could be malicious for people. Several issues have been taken into consideration in the Stryker Knee Replacement Recall in order to ensure that everything goes fine so that the perfect health standards could be maintained.
Class I Status Awarded To Stryker Knee Replacement Recall By FDA
Though it is considered as a healthy sign that Stryker has recalled its products and devices on time, things are not cozy in retrospect. Dealing with such serious is not a simple thing to manage as it is related to the lives of several people. The fact that these serious deformities have been categorized under Class I means that it could amount to death as well in some people. Being proactive by avoiding the products completely will prove to be most effective on an overall.
Stryker Knee Replacement Recall Is The Right Move At A Right Time
Just when more and more surgeons have started prescribing the product for their patients, the Stryker Knee Replacement Recall aspect has taken everyone aback. Moreover, there are health specialists who are puzzled over all the recent developments. One wonders that how such a product that passed all the stringent medical tests from a corporate perspective could every fail. Considering the fact that it has already been marketed extensively across the nation, it will be a huge setback medically and financially for people associated with the product in several ways. However, protecting the health of people is something that is more important than anything else.
By: W.C. Bohack
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