Class II — Potential Health Hazard

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

Novation Element Press-Fit Recalled by Exactech, Inc. Due to Eight (8) pieces did not receive the specified...

Date: September 23, 2015
Company: Exactech, 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 Exactech, Inc. directly.

Affected Products

Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation

Quantity: 8

Why Was This Recalled?

Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.

Where Was This Sold?

This product was distributed to 4 states: AZ, CO, FL, MD

Affected (4 states)Not affected

About Exactech, Inc.

Exactech, Inc. has 211 total recalls tracked by RecallDetector.

Related Recalls

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