Update: Settlement Agreement Signed November 2014
Stryker has agreed to settle cases for patients who had revision surgery to remove and replace defective Rejuvenate and ABGII hip implants. This agreement only applies to revision surgeries preformed before November 3, 2014. Contact us at 1-888-377-8900 regarding this and pending agreements.
Original Post
Yesterday, Stryker Corporation announced that its Instruments division received a warning letter from the FDA related to observations made during a November 2012 inspection at its Portage, Michigan location.
The letter concerns quality system observations made during the inspection. The FDA warning letter cites Stryker for the following:
- Failing to notify the FDA of a product recall;
- Marketing devices, including the Neptune Waste Management System, without a required 510(k) clearance.
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers like Stryker to notify the FDA of their intent to market a medical device at least 90 days in advance. This premarket notification allows the FDA to determine whether the device is equivalent to another device already in the market or a new device. There are two circumstances where a 510(k) is required:
- The company intends to introduce a device into commercial distribution for the first time;
- The company intends to reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.
The change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use of the medical device.
Stryker has submitted corrective action plans for the quality and recall issues, according to the company.
Our attroneys are providing free consultations to patients regarding a Stryker lawsuit. You can contact them for your FREE CONSULTATION HERE.
