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 Press-Fit Tapered Recalled by Exactech, Inc. Due to Devices were inadvertently sent to packaging and finished...

Date: April 12, 2016
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 Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.

Quantity: 1 device.

Why Was This Recalled?

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Where Was This Sold?

This product was distributed to 9 states: FL, HI, NJ, NY, OH, OK, RI, TN, VA

Affected (9 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