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

Zimmer Recalls NexGen Knee System Due to Component Mismatch

Zimmer, Inc. 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for unapproved component combinations.

Plain-English summary

Zimmer, Inc. is recalling 192,355 units of the NexGen Cruciate Retaining (CR) Complete Knee System. The recall involves specific femur, articular surface, patella, instrument, and provisional components. These devices are used in total knee arthroplasty for patients with severe pain.

The recall is being conducted because surgeons are implanting components in combinations that are not approved, specifically mixing micro and standard components. A previous recall in March 2012 reiterated proper combination labeling, but the mismatch problem continues. The affected devices were distributed nationwide in the United States and in Japan.

Healthcare providers should stop using the affected components and contact Zimmer, Inc. for further instructions. Patients who have had these devices implanted should contact their surgeon to discuss the recall and any necessary follow-up care.

The recalled product

Product: 65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 Femur CR POR FEM SURF HDN HATCP CMR, Rx, Sterile; 65597201433 Femur CR POR FEM SURF HDN HATCP DML, Rx, Sterile; 65597201434 Femur CR POR FEM SURF HDN HATCP DMR, Rx, Sterile; 65597201533 Femur…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
component-mismatch
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