Another Hernia Patch Recall by FDA

Image via WikipediaThe US Food and Drug Administration (FDA) issued another hernia and abdominal patch recall. The FDA on March 4, 2011 issued a Class 1 Recall Notice for Davol's XenMatric Surgical Graft.

The FDA indicated that the recall was issued because “Testing cannot confirm that all units of XenMatrix Surgical Graft are within FDA requirements for endotoxin levels. Several lots have been found to have elevated endotoxin levels. Endotoxins (pyrogens) are substances found in certain bacteria that, at elevated levels, can cause serious illness which can be fatal.”

This product was manufactured from June 1, 2010 through October 31, 2010 and distributed from July 1, 1010 through October 31, 2010. For more information, please see the FDA’s safety alert.

Litigation is pending against Davol, Inc. is pending in both federal and state court on behalf of patients who suffered serious injuries or complications related to the company’s Composix® Kugel® Mesh hernia repair patch.

Related articles

• Hernias: The Next Step in Compensating Workers
• Jury Awards $1.5 Million for Defective Hernia Patch
• Defective Artificial Hips may be a Costly problem for Workers' Compensation (workers-compensation.blogspot.com)
• Recall of Certain Composix Kugel Mesh Patches Used in Hernia Repair

Hip Implants Recalled Due to Failure

Johnson and Johnson has recalled 2 Hip Implants because of failure. The two implants were made by the DePuy Orthopaedics unit of Johnson and Johnson. The decision to withdrawn the products was based upon the fact that many patients require a second hip replacement because of product failure.

DePuy release a statement today that they two products being recalled were: the ASR XL Acetabular System, a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur, a method intended to preserve more bone. There about 93,000 of the defective appliances that have been implanted worldwide.

For over two years the US Food and Drug Administration (FDA) has been besieged with complaints about the failure of the devices and painful surgery to replace them.

The office of Jon L. Gelman has advocated for consumer rights and has helped those who have unfortunately received defective medical devices. Please call 1-973-696-7900 or e-mail for further information.

Workers' Compensation and Joint Replacement

• Preventing Joint Replacement Surgery in Workers' Compensation Claims 

Related articles

• J and J unit recalls hip replacement products (usatoday.com)
• J and J recalls 2 hip replacement systems for problems (sfgate.com)
• J and J Recalls 2 Hip Replacement Systems for Problems (abcnews.go.com)
• Johnson and Johnson Recalls Hip Implants (nytimes.com)