Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling 1,643 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 potential breach of the sterile barrier for a medical device, which poses a risk of harm (infection) even though specific injuries are not reported in the source text, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling 1,643 units of TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture (Part Number: 72202610). 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 biodegradable suture anchors were distributed worldwide, including in the United States, Canada, various European countries, and regions in Asia-Pacific, South America, and Africa. The agency has classified this as a Class II recall.
Healthcare providers and consumers should stop using the affected devices and contact Smith & Nephew for further instructions on returns or replacements.
The recalled product
- Product
- TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Affected units
- 1,643
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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