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Zimmer NexGen Complete Knee Solution MIS Tibial Components Recall

Zimmer NexGen Knee Recall - Why Joint Replacement Systems Recalls Happen

Zimmer NexGen Knee Recall
On September 13, 2010 Zimmer, Inc. announced a recall of its NexGen MIS Tibial Components due to the knee replacement component's potential for loosening and causing severe problems such as lack of mobility and stability (the knees' primary function), persistent pain, infection and osteoarthritis. The Zimmer NexGen MIS Tibial Components recall applies to an estimated 65,000 or more devices and could have been used in Zimmer NexGen CR, CR-Flex, Legacy Posterior Stabilized (LPS) and LPS-Flex knee replacement systems.

Read the FDA Recall Notice for the Zimmer NexGen MIS Tibial Components here

Persons impacted by the Zimmer NexGen MIS Tibial Components recall should have received an "Urgent Device Correction" letter from Zimmer prior to the recall announcement.

Why Joint Replacement Systems Recalls Happen

In recent years there have been a large number of joint replacement systems recalled, specifically hip and knee replacement systems. Joint replacement systems don't go through the same approval process and monitoring as medical devices such as implanted heart devices and pharmaceuticals do. Joint replacement systems are routinely approved for marketing by the FDA without testing in patients and ongoing monitoring. It is typically European health agencies that lead the way in either recalling faulty joint replacement systems, or barring them from the market before patients ever suffer from their problems. Because of this lack of monitoring, we are often unaware of problems as they initially develop or even to the full extent of the problems after they have occurred.

There are roughly 130,000 knee replacement surgeries annually in the US, with hip and knee replacements representing a $6.7 billion a year business.

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