Agency classClass IIOur severity:High FDA (Devices)·Z-2000-2013·Announced 2013-08-28

Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

Zimmer is recalling NexGen CR knee 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 involves a medical device used in surgery where unapproved component combinations are being implanted, representing a risk of harm where specific injury reports 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 192,355 devices, including CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals, which are used in total knee arthroplasty.

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 proper combination labeling, but the mismatch problem has continued.

The affected devices were distributed nationwide in the United States and in Japan. Patients who have had these knee components implanted should contact their surgeon or healthcare provider to discuss the recall and any necessary follow-up care.

The recalled product

Product: 00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx, Sterile; 00597201201 Femur CR POROUS FEM COMP SIZE BML Rx, Sterile; 00597201202 Femur CR POROUS FEM COMP SIZE BMR Rx, Sterile; Used in total knee…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: unapproved-combination
surgical-error
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