The Recall Desk
HighFDA (Devices)·Z-2017-2013·Announced 2013-08-28

Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

Zimmer, Inc. is recalling NexGen Cruciate Retaining knee implant 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 no specific injuries or illnesses are reported in the source text.

Plain-English summary

Zimmer, Inc. is recalling specific components of the NexGen Cruciate Retaining (CR) Complete Knee System. The affected products include CR Micro Femurs, Articular Surfaces, Patellae, instruments, and provisionals. These devices are used in total knee arthroplasty and are indicated for patients with severe pain.

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 affected devices were distributed nationwide in the United States and in Japan.

Healthcare providers should stop using the affected components in unapproved combinations. Patients who have had these implants should contact their healthcare provider for guidance.

The recalled product

Product
90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile; 90595202020 Articular Surface XLPE CR ART SURF AE12/PUR 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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