The U.S. Food and Drug Administration (FDA) has warned that a Stryker product used to assist surgeons in cutting and marking bone during knee implants could cause serious complications. The voluntary Stryker recall issued in November 2012 was labeled a Class I recall by the FDA, meaning the device is likely to cause injury or death.
Surgeon complaints revealed that Stryker may not have received approval for its ShapeMatch Cutting Guides, which could lead to failing knee implants. The company is also facing patient complaints related to its Stryker Rejuvenate and ABG II hip replacements.
Stryker issued a Rejuvenate and ABG II recall in 2012 after its metal-on-metal implants were found to cause severe hip problems. Patients with the devices have complained of pain, swelling, bone deterioration and metal poisoning known as metallosis.