Class II — Potential Health Hazard

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

SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Recalled by Smith & Nephew, Inc. Endoscopy Division Due to Sterility of device is compromised due to breach...

Date: June 2, 2014
Company: Smith & Nephew, Inc. Endoscopy Division
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 Smith & Nephew, Inc. Endoscopy Division directly.

Affected Products

SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue

Quantity: 136 units

Why Was This Recalled?

Sterility of device is compromised due to breach in sterile barrier

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Smith & Nephew, Inc. Endoscopy Division

Smith & Nephew, Inc. Endoscopy Division has 37 total recalls tracked by RecallDetector.

Related Recalls

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