Class II — Potential Health Hazard

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

TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture Recalled by Smith & Nephew, Inc. Endoscopy Division Due to Pinholes detected in a small number of primary...

Date: August 6, 2013
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

TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 Biodegradable suture anchor

Quantity: 6985 US

Why Was This Recalled?

Pinholes detected in a small number of primary pouches that may constitute a breach of the 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