Smith & Nephew Recalls Bioraptor Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling Bioraptor 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
What this means for you
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 risk-of-harm product (sterile barrier breach) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling the BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture (Catalog Number 72200689). The recall involves 240 units distributed worldwide, including the United States, Canada, Europe, Asia-Pacific, and other regions.
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.
Healthcare providers and facilities should stop using the affected suture anchors and contact Smith & Nephew for further instructions on handling or returning the product.
The recalled product
- Product
- BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Affected units
- 240
Distribution
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 →Related recalls
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