Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for unapproved combinations.
Plain-English summary
Zimmer, Inc. is recalling specific components of the NexGen Cruciate Retaining (CR) Complete Knee System. The recall involves 192,355 devices, including CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals, which are indicated for total knee arthroplasty in patients with severe pain.
The recall is being conducted because surgeons are implanting these components in combinations that are not approved, specifically mixing micro components with standard components. Although a March 2012 recall reiterated the proper combination labeling, the mismatch problem has continued. The affected devices were distributed nationwide in the United States and in Japan.
Consumers and healthcare providers should contact Zimmer, Inc. for further instructions on how to handle the recalled devices. The source text does not specify the exact corrective actions or contact details for the recall.
The recalled product
- Product
- 00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile; 00597001132 Femur CR PRC SURF HDN FEM CO-NID AMR, Rx, Sterile; 00597001231 Femur CR PRC SURF HDN FEM C
- 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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