Class II — Potential Health Hazard

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

Medacta GMK HINGE Recalled by Medacta Usa Inc Due to One lot of product does not include a...

Date: May 19, 2017
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

Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

Quantity: 4 units

Why Was This Recalled?

One lot of product does not include a screw for attachment to the tibial base plate.

Where Was This Sold?

This product was distributed to 3 states: AZ, CA, NC

Affected (3 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