Class II — Potential Health Hazard

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

BioSync Anatomic Cotton Wedge Recalled by Arthrex, Inc. Due to Potential for polystyrene particulate presence.

Date: April 22, 2016
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

BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

Quantity: 138 total products

Why Was This Recalled?

Potential for polystyrene particulate presence.

Where Was This Sold?

This product was distributed to 15 states: CA, CO, FL, GA, IL, IN, KS, MD, NY, NC, PA, SC, VA, WA, WI

Affected (15 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