Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling TWINFIX Ultra 5.5 mm PLLA-HA 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 infection or harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling 2,038 units of TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchors with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles, Part Number 72202616. The recall was initiated because pinholes were detected in a small number of primary pouches, which may constitute a breach of the sterile barrier.
The affected devices are biodegradable suture anchors distributed worldwide, including in the United States, Canada, Europe, Asia-Pacific, and other regions. The specific lot codes associated with this recall are listed in the agency's structured data. No specific dates of manufacture or distribution are provided in the source text.
Healthcare providers and facilities should stop using the affected suture anchors and contact Smith & Nephew for further instructions on how to return or dispose of the devices. Patients who have already received these devices should contact their healthcare provider for guidance.
The recalled product
- Product
- TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Affected units
- 2,038
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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