Class II — Potential Health Hazard

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

Custom Made Implant System with Minimum Invasive Grower (MIG) component Recalled by Howmedica Osteonics Corp. Due to From March 2007 to October 2014, product did...

Date: December 21, 2017
Company: Howmedica Osteonics Corp.
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 Howmedica Osteonics Corp. directly.

Affected Products

Custom Made Implant System with Minimum Invasive Grower (MIG) component

Quantity: 5

Why Was This Recalled?

From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.

Where Was This Sold?

This product was distributed to 3 states: FL, KS, NY

Affected (3 states)Not affected

About Howmedica Osteonics Corp.

Howmedica Osteonics Corp. has 229 total recalls tracked by RecallDetector.

Related Recalls

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