Zimmer NexGen Knee Components Recalled for Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining knee components because surgeons are implanting them in unapproved combinations.
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 is classified as FDA Class II, and the hazard involves the use of medical devices in unapproved combinations, which poses a risk of harm even though specific injuries are not detailed in the provided text.
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. The issue is that surgeons are implanting these components in combinations that are not approved, specifically combining micro components with standard components.
The recall is being issued because a previous recall in March 2012 reiterated the proper combination labeling, but the mismatch problem continues. The devices are indicated for patients with severe pain undergoing total knee arthroplasty. The affected devices were distributed nationwide in the United States and in Japan.
Surgeons and healthcare providers should stop using the affected components in unapproved combinations. Zimmer is removing the devices from the market to prevent the continued use of these unapproved combinations.
The recalled product
- Product
- 00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597002012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597002014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Steri
- 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
- 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
- HighZimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
FDA (Devices) · 2013-08-28