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 Hip End Effector Recalled by Mako Surgical Corporation Due to Characterization issue associated with the product. This issue...

Date: July 9, 2020
Company: Mako Surgical Corporation
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 Mako Surgical Corporation directly.

Affected Products

Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167

Quantity: 12 units

Why Was This Recalled?

Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.

Where Was This Sold?

This product was distributed to 8 states: AZ, CA, FL, MN, NY, RI, TN, TX

Affected (8 states)Not affected

About Mako Surgical Corporation

Mako Surgical Corporation has 27 total recalls tracked by RecallDetector.

Related Recalls

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