Class II — Potential Health Hazard

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

Evans Wedge Disposable Trials Recalled by restor3d Inc. Due to During re-work of disposable instruments to relabel for...

Date: March 30, 2022
Company: restor3d 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 restor3d Inc. directly.

Affected Products

Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument

Quantity: 9 units

Why Was This Recalled?

During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About restor3d Inc.

restor3d Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

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