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.
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 TWINFIX Ultra PLLA/HA 6.5 mm suture anchors with 2 ULTRABRAID Suture, White / Black (Part Number: 72202608). The recall involves 1,308 units that were distributed nationwide in the United States and in various countries across Europe, Asia-Pacific, and the Americas.
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 instructions on how to return or dispose of the product.
The recalled product
- Product
- TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Hazard
- Affected units
- 1,308
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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