Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
Smith & Nephew is recalling 259 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.
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 compromised sterile barrier, which poses a risk of infection (risk-of-harm product), but the source text does not report any specific illnesses or injuries, placing it in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling 259 units of SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue (Product Code: 72203841). The recall is due to a breach in the sterile barrier, which compromises the sterility of the device. The affected lots are 50476555 and 50481446.
The devices were distributed nationwide in the United States and internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden. The product is a nondegradable soft tissue fixation fastener.
Consumers and healthcare providers should stop using the affected devices and contact Smith & Nephew for further instructions on return or replacement.
The recalled product
- Product
- SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Affected units
- 259
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: 50476555
- 50481446
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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