Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations
Zimmer is recalling NexGen Cruciate Retaining knee components because surgeons are implanting them in unapproved combinations. The issue persists despite a previous 2012 recall.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used in surgery where unapproved component combinations pose a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer, Inc. is recalling specific components of the NexGen Cruciate Retaining (CR) Complete Knee System. The recall involves CR Micro Femurs, Articular Surfaces, Patellae, instruments, and provisionals. These components are used in total knee arthroplasty for patients with severe pain.
The recall is being conducted because surgeons are implanting these components in combinations that are not approved, specifically combining micro components with standard components. A previous recall in March 2012 reiterated the proper combination labeling, but the mismatch problem has continued.
The affected devices were distributed nationwide in the United States and in Japan. The source text does not specify the number of affected units or report any specific injuries or illnesses. Consumers and healthcare providers should contact Zimmer, Inc. for further instructions on handling these devices.
The recalled product
- Product
- 00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-FLEX POR FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 192,355
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 47 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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