Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
Smith & Nephew is recalling 136 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. A compromised sterile barrier on a medical device used for soft tissue fixation presents a significant risk of infection, which aligns with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling 136 units of SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture (Product Code: 72203842). The recall is due to a breach in the sterile barrier, which compromises the sterility of the device.
The affected lots are 50477397 and 50481448. The products were distributed nationwide in the United States and internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
Consumers and healthcare providers should stop using the affected devices and contact Smith & Nephew for further instructions.
The recalled product
- Product
- SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Affected units
- 136
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 (2)
- Lot Numbers: 50477397
- 50481448
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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 5 products in this recall →Related recalls
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