Agency classClass IIOur severity:High FDA (Devices)·Z-2231-2013·Announced 2013-09-25

Smith & Nephew Recalls TWINFIX Ultra HA Suture Anchors Due to Sterile Breach

Smith & Nephew is recalling TWINFIX Ultra HA 5.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential breach of the sterile barrier for a medical device, which poses a risk of harm even without reported injuries.

Plain-English summary

Smith & Nephew, Inc. Endoscopy Division is recalling TWINFIX Ultra HA 5.5 mm Suture Anchors with 2 ULTRABRAID Suture, Blue / Black (Part Number: 72202626). The recall involves 3,827 units distributed in the United States and internationally.

The recall was initiated because pinholes were detected in a small number of primary pouches. These pinholes may constitute a breach of the sterile barrier, which could compromise the sterility of the medical device.

The affected products were distributed nationwide in the United States and in various countries across Europe, Asia-Pacific, and the Americas. Healthcare providers and facilities should stop using the affected lots and contact the manufacturer for further instructions.

The recalled product

Product: TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
Manufacturer: Smith & Nephew, Inc. Endoscopy Division
Category: Medical Device — Surgical Anchors
Hazard: sterile-breach
infection-risk
Affected units: 3,827

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 26 recalled by Smith & Nephew, Inc. Endoscopy Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 26 products in this recall →

Same manufacturer · Smith & Nephew, Inc. Endoscopy Division

See all →

High
Smith & Nephew Recalls SUTUREFIX Ultra S Suture Due to Sterility Breach
FDA (Devices) · 2014-07-23
High
Smith & Nephew Recalls SUTUREFIX Ultra S Sutures Due to Sterility Breach
FDA (Devices) · 2014-07-23
High
Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
FDA (Devices) · 2014-07-23
Severe
Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
FDA (Devices) · 2014-07-23
High
Smith & Nephew Recalls SUTUREFIX Ultra S Devices Due to Sterility Breach
FDA (Devices) · 2014-07-23

Same hazard · sterile breach