The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2218-2013·Announced 2013-09-25

Smith & Nephew Recalls Bioraptor Suture Anchors Due to Sterile Barrier Breach

Smith & Nephew is recalling Bioraptor 2.9 mm Suture Anchors because pinholes in the 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential sterile barrier breach without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Smith & Nephew, Inc. Endoscopy Division is recalling the BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture (Part Number: 72200690). The recall involves 725 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 product is a biodegradable suture anchor used in medical procedures. The recall covers units distributed worldwide, including the United States, Canada, Europe, Asia-Pacific, and other regions. Users should stop using the affected product and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
Category
Medical Device — Surgical Suture Anchors
Hazard
Affected units
725

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 →

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