Agency classClass IIOur severity:High FDA (Devices)·Z-2015-2013·Announced 2013-08-28

Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations, mixing 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for FDA Class II recalls without reported hospitalizations or fatalities.

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. The issue arises 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. The affected devices are used in total knee arthroplasty and are indicated for patients with severe pain. The recall covers 192,355 devices distributed nationwide in the United States and in Japan.

Consumers and healthcare providers should contact Zimmer, Inc. for further information regarding the recall and proper device usage. The source text does not specify specific actions for patients who have already received the implants, other than the general context of the recall.

The recalled product

Product: 00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 00597206132 Patella ALL POLY PAT COMP MICRO 32DIA, Rx, Sterile; 00597206135 Patella ALL POLY PAT COMP MICRO 35DIA, Rx, Sterile; Used in…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
improper-use
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.

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 · mis labeling