Agency classClass IIOur severity:High FDA (Devices)·Z-2234-2013·Announced 2013-09-25

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

Smith & Nephew is recalling 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 no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Smith & Nephew, Inc. Endoscopy Division is recalling TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchors with 3 ULTRABRAID Suture (Part Number: 72202603). The recall is due to the detection of pinholes in a small number of primary pouches, which may constitute a breach of the sterile barrier.

The affected products were distributed worldwide, including in the United States, Canada, various European countries, and regions in Asia-Pacific, South America, and Africa. The source text does not specify the exact number of units affected or report any illnesses or injuries associated with the defect.

Healthcare providers and consumers should stop using the affected suture anchors and contact Smith & Nephew for further instructions or a replacement.

The recalled product

Product: TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor
Manufacturer: Smith & Nephew, Inc. Endoscopy Division
Category: Medical Device — Surgical Suture Anchors
Hazard: sterile-barrier-breach
infection-risk

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