Agency classClass IIOur severity:High FDA (Devices)·Z-1998-2013·Announced 2013-08-28

Zimmer NexGen Knee System Components Recalled for Unapproved 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 involves a high-risk medical device where unapproved combinations are being implanted, representing a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Zimmer, Inc. is recalling specific components of the NexGen Cruciate Retaining (CR) Complete Knee System. The affected products include CR Micro Femurs, Articular Surface, Patellae, instruments, and provisionals. The recall involves 192,355 devices 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 mixing micro components with standard components. A previous recall in March 2012 reiterated the proper combination labeling, but the mismatch problem has continued. These devices are used in total knee arthroplasty for patients with severe pain.

Consumers and healthcare providers should contact Zimmer, Inc. for further information regarding the recall and proper device usage.

The recalled product

Product: 00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE…
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 (2)

REF 00597001101
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.

See all →

High
Zimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
High
Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
High
Zimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
Moderate
Persona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
High
Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide Recall
FDA (Devices) · 2026-07-01

Same hazard · unapproved combination