The Recall Desk
HighFDA (Devices)·Z-2023-2013·Announced 2013-08-28

Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

Zimmer, Inc. is recalling NexGen CR knee implant components because surgeons are using them in unapproved combinations. The recall covers 192,355 devices distributed in the US and Japan.

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 presents a risk of harm even though specific injury reports 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 Articular Surface components (catalog numbers 90595203117 and 90595203120) and other system parts, including CR Micro Femurs, Patellae, instruments, and provisionals. A total of 192,355 devices are affected by this action.

The recall is being conducted because surgeons are implanting these components in combinations that are not approved, specifically combining micro components with standard components. Although a previous recall in March 2012 reiterated the proper combination labeling, the mismatch problem has continued. The devices are indicated for total knee arthroplasty in patients with severe pain.

The affected devices were distributed nationwide in the United States and in Japan. Healthcare providers and patients should contact Zimmer, Inc. for further information regarding the proper use of these components and the recall process.

The recalled product

Product
90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile; 90595203120 Articular Surface XLPE CR ART SURF AE34/STYEL 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

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Same hazard · unapproved combination

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