Agency classClass IIOur severity:High FDA (Devices)·Z-2236-2013·Announced 2013-09-25

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

Smith & Nephew is recalling 1,643 TWINFIX Ultra 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 involves a potential breach of the sterile barrier for a medical device, which poses a risk of harm (infection) even though specific injuries are not reported in the source text, fitting the High severity criteria for risk-of-harm products.

Plain-English summary

Smith & Nephew, Inc. Endoscopy Division is recalling 1,643 units of TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture (Part Number: 72202610). The recall is due to pinholes detected in a small number of primary pouches, which may constitute a breach of the sterile barrier.

The affected biodegradable suture anchors were distributed worldwide, including in the United States, Canada, various European countries, and regions in Asia-Pacific, South America, and Africa. The agency has classified this as a Class II recall.

Healthcare providers and consumers should stop using the affected devices and contact Smith & Nephew for further instructions on returns or replacements.

The recalled product

Product: TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor
Manufacturer: Smith & Nephew, Inc. Endoscopy Division
Category: Medical Device — Surgical Suture Anchor
Hazard: sterile-barrier-breach
infection-risk
Affected units: 1,643

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 barrier breach