Class II — Potential Health Hazard

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

Low Profile Screw Recalled by Arthrex, Inc. Due to Screws provided in the device package are 6...

Date: October 1, 2019
Company: Arthrex, 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 Arthrex, Inc. directly.

Affected Products

Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.

Quantity: 20 units

Why Was This Recalled?

Screws provided in the device package are 6 mm longer than intended.

Where Was This Sold?

This product was distributed to 6 states: MA, MN, ND, OH, SD, TN

Affected (6 states)Not affected

About Arthrex, Inc.

Arthrex, Inc. has 28 total recalls tracked by RecallDetector.

Related Recalls

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