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 potential breach of the sterile barrier for a medical device, which poses a risk of harm (infection) even though no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchors with 3 ULTRABRAID Suture (Part Number: 72202603). The recall is due to the detection of pinholes in a small number of primary pouches, which may constitute a breach of the sterile barrier.
The affected products were distributed worldwide, including in the United States, Canada, various European countries, and regions in Asia-Pacific, South America, and Africa. The source text does not specify the exact number of units affected or report any illnesses or injuries associated with the defect.
Healthcare providers and consumers should stop using the affected suture anchors and contact Smith & Nephew for further instructions or a replacement.
The recalled product
- Product
- TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
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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