A qualified Ethicon recall lawyer can help determine if you or a loved one has been affected by this recalled product. If you think your loved one may be eligible to file a lawsuit, you can fill out the form on this page to get a free case evaluation. If you or a loved one is a victim of this recalled product, you may be able to receive compensation for your injuries or losses.
Ethicon voluntarily recalled surgical staplers
In an effort to protect patients and improve overall patient safety, the manufacturer of Ethicon surgical staplers voluntarily recalled over 500 lots of its Proximate brand. The recalled Proximate PPH and HCS hemorrhoidal circular staplers may have an improper firing stroke that can result in incomplete staple formation. Affected healthcare providers are encouraged to return the products to Ethicon for a full refund or credit.
Malformed staples produced by Ethicon are a common issue during surgery. This can lead to severe complications such as prolonged surgery, postoperative connection leak, hemorrhage, and even death. The company says that it is not aware of any other injuries associated with its staplers, but has received reports of several incidents of malformed staples. The company is investigating the occurrence of injuries related to the staplers and will contact victims if necessary.
Components in recalled staplers may be out of specification
A recent recall by Ethicon, a Johnson & Johnson subsidiary, involves recalled Ethicon recall lawyer staplers. These devices contain an out-of-spec component that can result in malformed staples. These staples can irritate the patient’s skin and prolong or require additional surgeries. Although the defect is relatively rare, it can result in serious injury or death. Affected Ethicon staplers were on the market for several months before the recall, meaning that thousands of surgeries could have taken place during that time.
The Ethicon stapler recall is a Class I event, meaning the surgical device has a faulty component. This component may be out of specification and cause complications like prolonged surgeries, postoperative connection leaks, hemorrhage, or even death. The FDA also noted that the faulty staplers can also result in postoperative complications such as infection and blood loss. The failure of these devices could even result in death or severe injury.
Additional premarket reviews required
If you’re considering a case against the maker of the recalled Prolift hernia repair mesh, you might want to take a look at the premarket review process for medical devices. This process involves extensive submissions from the manufacturer, and requires additional reviews in order to be approved for sale. An Ethicon recall lawyer can help you navigate the process and determine whether your claim is valid.
The case centers on a conflict between the SS 510(k) regulatory scheme and state law. As a result, Ethicon argues that it could not redesign the Prolift without the FDA’s approval. Further, the FDA had to approve the changes to the Prolift before the company could take it to market. As a result, Ethicon’s argument that the state law preempted the federal regulation is not a valid defense in this case.
Malformed staples a concern
The FDA has announced a new recall regarding certain types of Ethicon surgical staplers. These staplers contain a component that is not in specification and can cause serious surgical complications. The staplers were intended to be used on internal tissue during minimally invasive surgery. Ethicon is currently investigating the problem. The FDA has warned physicians that use of these staplers may cause serious injuries or even death.
The company is responsible for the recalled Echelon Flex Endopath Staplers, which are defective and do not form the required staples. The recall has resulted in over 5,700 recalls across the United States and the risk of malformed staples is extremely high. Malformed staples can cause severe injuries and may compromise the integrity of an anastomose. If you or a loved one has had a surgical procedure with these staplers, you may be entitled to compensation for your medical expenses.