Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in the 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 specific injuries or illnesses are reported in the source text.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchors with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles, Part Number 72202620. The recall involves 314 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 nationwide in the United States and in various countries across Europe, Asia-Pacific, and the Americas. Healthcare providers and facilities should stop using the affected lots and contact Smith & Nephew for further instructions.
The recalled product
- Product
- TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Affected units
- 314
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 50373721 50375642 50397595 50397598 50397604 50397607 50449548
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
Same manufacturer · Smith & Nephew, Inc. Endoscopy Division
See all →- HighSmith & Nephew Recalls SUTUREFIX Ultra S Suture Due to Sterility Breach
FDA (Devices) · 2014-07-23
- HighSmith & Nephew Recalls SUTUREFIX Ultra S Sutures Due to Sterility Breach
FDA (Devices) · 2014-07-23
- HighSmith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
FDA (Devices) · 2014-07-23
- SevereSmith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
FDA (Devices) · 2014-07-23
- HighSmith & Nephew Recalls SUTUREFIX Ultra S Devices Due to Sterility Breach
FDA (Devices) · 2014-07-23
Same hazard · sterile barrier breach
See all →- ModerateBoston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
FDA (Devices) · 2026-08-12
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- ModeratePhantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
FDA (Devices) · 2026-07-29
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27