Agency classClass IIOur severity:High FDA (Devices)·Z-2025-2013·Announced 2013-08-28

Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System 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 to patients, although 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 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 addressed proper combination labeling, but the mismatch problem has continued.

Healthcare providers and patients should be aware that these devices are indicated for total knee arthroplasty in patients with severe pain. Zimmer is removing the devices from the market to prevent the use of unapproved combinations.

The recalled product

Product: 90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx, Sterile; 90597003112 Articular Surface CR ART SURF 34/STR YEL 12MM, Rx, Sterile; 90597003114 Articular Surface CR ART SURF 34/STR YEL…
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 →

Same manufacturer · Zimmer, Inc.

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Same hazard · unapproved combination