Agency classClass IIOur severity:High FDA (Devices)·Z-2030-2013·Announced 2013-08-28

Zimmer NexGen Knee System Recalled for Unapproved Component Combinations

Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

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 unapproved component combinations in a high-risk medical device, which fits the criteria for a High severity rating where injury has not yet been reported.

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 Surfaces, Patellae, instruments, and provisionals, which were 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 continues. These devices are used in total knee arthroplasty and are indicated for patients with severe pain.

Healthcare providers and patients who have received these implants should contact Zimmer, Inc. for further instructions regarding the recall and potential corrective actions.

The recalled product

Product: 00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile; 00597004110 Articular Surface CR ART SURF 56/STRIPE GREEN 10, Rx, Sterile; 00597004112 Articular Surface CR ART SURF 56/STRIPE GREEN 12, Rx, Sterile; 00597004114 Articular Surface CR ART SURF…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: unapproved-combination
implant-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 →

Same manufacturer · Zimmer, Inc.

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Same hazard · unapproved combination