The Recall Desk
HighFDA (Devices)·Z-2012-2013·Announced 2013-08-28

Zimmer NexGen Knee System Components Recalled for Unapproved 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 unapproved component combinations are being used, posing 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 recall involves 192,355 devices, including CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals. These devices are indicated for use in total knee arthroplasty for patients with severe pain.

The recall is being conducted because surgeons are implanting components in combinations that are not approved, specifically mixing micro components with standard components. A previous recall in March 2012 reiterated proper combination labeling, but the mismatch problem has continued. The devices were distributed nationwide in the United States and in Japan.

Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the removal of these devices from use. The source text does not specify the exact actions consumers or patients should take beyond the general context of a recall.

The recalled product

Product
00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile; 00597201433 Femur CR POR SURF HDN FEM CO-NID DML, Rx, Sterile; 00597201434 Femur CR POR SURF HDN FEM CO-NID DMR, Rx, Sterile; 00597201533 Femu
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

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Same hazard · unapproved combination

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