Agency classClass IIOur severity:High FDA (Devices)·Z-2018-2013·Announced 2013-08-28

Zimmer NexGen Knee Components Recalled for Unapproved Combinations

Zimmer, Inc. is recalling NexGen Cruciate Retaining knee components because surgeons are implanting them in unapproved combinations.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 poses a risk of harm even though specific injuries 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 CR Micro Femurs, Articular Surfaces, Patellae, instruments, and provisionals. The issue is that surgeons are implanting these components in combinations that are not approved, specifically combining micro components with standard components.

The recall is being issued because a previous recall in March 2012 reiterated the proper combination labeling, but the mismatch problem continues. The devices are indicated for patients with severe pain undergoing total knee arthroplasty. The affected devices were distributed nationwide in the United States and in Japan.

Surgeons and healthcare providers should stop using the affected components in unapproved combinations. Zimmer is removing the devices from the market to prevent the continued use of these unapproved combinations.

The recalled product

Product: 00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597002012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597002014 Articular Surface CR ART SURF 12/PURPLE 14, Rx…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: unapproved-combination
device-mismatch
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 →

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Same hazard · unapproved combination