Class II — Potential Health Hazard

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

MAKO Integrated Cutting System (MICS) HANDPIECE Recalled by Howmedica Osteonics Corp. Due to Stryker has identified an issue with the characterization...

Date: August 7, 2024
Company: Howmedica Osteonics Corp.
Status: Ongoing
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

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

Quantity: 897 units

Why Was This Recalled?

Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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