Smith & Nephew Recalls TWINFIX Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling TWINFIX Ultra HA 4.5 mm 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 is classified as FDA Class II. The hazard involves a potential breach of the sterile barrier, which is a risk-of-harm scenario for a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling TWINFIX Ultra HA 4.5 mm Suture Anchors with 2 ULTRABRAID Suture, White / Blue (Part Number: 72202597). The recall involves 8,889 units distributed in the United States and internationally.
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 affected products were distributed worldwide, including in the United States, Canada, various European countries, and regions in Asia-Pacific, South America, and Africa. Healthcare providers and facilities should check their inventory for the specific part number and lot codes listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or their authorized representative.
The recalled product
- Product
- TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Affected units
- 8,889
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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