The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2046-2014·Announced 2014-07-23

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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Category
Medical Device — Surgical Fasteners
Hazard
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 →

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