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, posing a risk of infection.
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 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 TWINFIX Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles, Part Number 72202612. The recall involves 1,571 units distributed in the United States and internationally across 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. The agency has classified this as a Class II recall.
Healthcare providers and facilities that have received these specific suture anchors should stop using them and contact Smith & Nephew for instructions on how to return the product. Patients who have already had these anchors implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Affected units
- 1,571
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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