Class II — Potential Health Hazard

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

Smart Toe II Intramedullary Arthrodesis Implant Recalled by Stryker GmbH Due to The nickel-sensitivity statement on the outer carton may...

Date: March 28, 2022
Company: Stryker GmbH
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 Stryker GmbH directly.

Affected Products

Smart Toe II Intramedullary Arthrodesis Implant

Quantity: 246 implants

Why Was This Recalled?

The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stryker GmbH

Stryker GmbH has 68 total recalls tracked by RecallDetector.

Related Recalls

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