Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NexGen Augment Recalled by Zimmer, Inc. Due to The affected lot is being recalled because it...

Date: April 2, 2015
Company: Zimmer, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer, Inc. directly.

Affected Products

NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.

Quantity: 20 units

Why Was This Recalled?

The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery

Where Was This Sold?

This product was distributed to 4 states: FL, IL, IN, MN

Affected (4 states)Not affected

About Zimmer, Inc.

Zimmer, Inc. has 437 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report