Agency classClass IIOur severity:High FDA (Devices)·Z-2022-2013·Announced 2013-08-28

Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

Zimmer, Inc. is recalling NexGen Cruciate Retaining 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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.

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. These devices were distributed nationwide in the United States and in Japan.

The recall is being conducted because surgeons are implanting the components in combinations that are not approved, specifically combining micro components with standard components. A previous recall in March 2012 reiterated the proper combination labeling, but the mismatch problem has continued. The devices are indicated for use in total knee arthroplasty for patients with severe pain.

The recalled product

Product: 00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile; 00595203112 Articular Surface XLPE CR ART SURF 3,4/SYEL 12, Rx, Sterile; 00595203114 Articular Surface XLPE CR ART SURF 3,4/SYEL 14, Rx, Sterile; 00595203117 Articular Surface XLPE CR ART SURF…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
unapproved-combination
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