The Recall Desk
HighFDA (Devices)·Z-2049-2014·Announced 2014-07-23

Smith & Nephew Recalls SUTUREFIX Ultra S Sutures Due to Sterility Breach

Smith & Nephew is recalling 763 units of SUTUREFIX Ultra S Double Loaded Sutures because the sterile barrier was breached, compromising 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 involves a compromised sterile barrier on a medical device, which presents a risk of infection (harm) but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Smith & Nephew, Inc. Endoscopy Division is recalling 763 units of SUTUREFIX Ultra S Double Loaded Sutures (Product Code: 72203854). The recall is due to a breach in the sterile barrier, which compromises the sterility of the medical device.

The affected lots are 50478984, 50485736, 50485737, 50485738, 50487831, 50491901, and 50493684. These 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.

Healthcare providers and consumers should stop using these specific lots of sutures and contact Smith & Nephew for further instructions or a replacement.

The recalled product

Product
SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
Category
Medical Device — Surgical Sutures
Hazard
Affected units
763

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 (7)

  • Lot Numbers: 50478984
  • 50485736
  • 50485737
  • 50485738
  • 50487831
  • 50491901
  • 50493684

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

Same manufacturer · Smith & Nephew, Inc. Endoscopy Division

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Same hazard · infection

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