Smith & Nephew Recalls Bioraptor Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling 1,735 Bioraptor 2.9 mm suture anchors because pinholes in the 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 is classified as FDA Class II and involves a potential sterile barrier breach, which poses a risk of infection (harm) without reported injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling 1,735 units of the BIORAPTOR 2.9 mm Suture Anchor with DURABRAID Suture (Part Number: 72200783). 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 devices are biodegradable suture anchors distributed worldwide, including in the United States, Canada, Europe, Asia-Pacific, and other regions. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and facilities should stop using the affected suture anchors and contact Smith & Nephew for further instructions on returns or replacements.
The recalled product
- Product
- BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Affected units
- 1,735
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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