Class II — Potential Health Hazard

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

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 Recalled by Medacta Usa Inc Due to A Size 2 trial baseplate was assembled with...

Date: April 13, 2022
Company: Medacta Usa 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 Medacta Usa Inc directly.

Affected Products

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

Quantity: 50 units

Why Was This Recalled?

A Size 2 trial baseplate was assembled with Size 1 instrument sets.

Where Was This Sold?

This product was distributed to 7 states: AK, CA, CT, IN, MA, NJ, PA

Affected (7 states)Not affected

About Medacta Usa Inc

Medacta Usa Inc has 16 total recalls tracked by RecallDetector.

Related Recalls

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