The Recall Desk
HighFDA (Devices)·Z-2029-2013·Announced 2013-08-28

Zimmer NexGen Knee Components Recalled for Unapproved Combinations

Zimmer is recalling NexGen Cruciate Retaining knee 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 the hazard is the use of unapproved component combinations, and no specific injuries or illnesses are reported in the source text.

Plain-English summary

Zimmer, Inc. is recalling specific NexGen Cruciate Retaining (CR) Complete Knee System components, including CR Micro Femurs, Articular Surfaces, 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.

These devices are used in total knee arthroplasty and are indicated for patients with severe pain. The source text does not specify the exact actions consumers or healthcare providers should take beyond the context of the ongoing recall.

The recalled product

Product
90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; 90595204120 Articular Surface XLPE CR ART SURF AE56/STGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implants
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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