The Recall Desk
HighFDA (Devices)·Z-2002-2013·Announced 2013-08-28

Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

Zimmer, Inc. is recalling NexGen Cruciate Retaining (CR) Complete Knee System 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 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 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 affected items include CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals. The recall involves 192,355 devices 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. Zimmer is removing the devices from the market to address this issue.

Patients who have had these knee components implanted should contact their surgeon to determine if they are affected by this specific combination issue. Consumers should not attempt to remove or alter the devices themselves.

The recalled product

Product
00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx, Sterile; 00597201231 Femur CR POR SURF HDN FEM CO-NID BML Rx, Sterile; 00597201232 Femur CR POR SURF HDN FEM CO-NID BMR Rx, Sterile; Used in total knee
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
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.

See all 47 products in this recall →

Related recalls

Same manufacturer · Zimmer, Inc.

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Same hazard · unapproved combination

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