The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2045-2014·Announced 2014-07-23

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category
Medical Device — Surgical Fasteners
Hazard
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 →

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