Zimmer NexGen Knee System Recalled for Unapproved Component Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining 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 medical device where the hazard is the use of unapproved component combinations, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
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 were distributed nationwide in the United States and in Japan.
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 devices are indicated for use in total knee arthroplasty for patients with severe pain.
Consumers and healthcare providers should contact Zimmer, Inc. for further instructions on how to handle the affected devices.
The recalled product
- Product
- 00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP SIZE CMR Rx, Sterile; 00597201403 Femur CR POR FM COMP SIZE DML Rx, Sterile; 00597201404 Femur CR POR FM COMP SIZE DMR Rx, Sterile; 00597201503 Femur CR POR FM COMP SIZE EML Rx
- 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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Same hazard · unapproved combination
See all →- HighZimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
FDA (Devices) · 2013-08-28
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FDA (Devices) · 2013-08-28
- HighZimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
FDA (Devices) · 2013-08-28
- HighZimmer Recalls NexGen Knee Components Due to Unapproved Combinations
FDA (Devices) · 2013-08-28
- HighZimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
FDA (Devices) · 2013-08-28