Agency classClass IIOur severity:High FDA (Devices)·Z-2006-2013·Announced 2013-08-28

Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

Zimmer, Inc. is recalling NexGen Cruciate Retaining 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 medical device, which poses a risk of harm even though specific injuries are not detailed 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 CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals that are being combined with standard components. These specific combinations are not approved for use.

The recall is being issued because surgeons are implanting these components in unapproved combinations, specifically mixing micro and standard parts. A previous recall in March 2012 reiterated the proper combination labeling, but the mismatch problem continues. The affected products are used in total knee arthroplasty and are indicated for patients with severe pain.

The recall covers 192,355 units distributed nationwide in the United States and in Japan. Consumers and healthcare providers should stop using these components in the unapproved combinations described. Zimmer is removing the devices from the market to address the labeling and usage issues.

The recalled product

Product: 00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 00595001202 Femur CR-FLEX PCT FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: unapproved-combination
mis-labeling
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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