The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2048-2014·Announced 2014-07-23

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

Smith & Nephew is recalling SUTUREFIX Ultra S sutures because the sterile barrier is compromised, posing a risk of infection.

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), but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smith & Nephew, Inc. Endoscopy Division is recalling 1,086 units of SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white), Product Code 72203853. The recall is due to a breach in the sterile barrier, which compromises the sterility of the device.

The affected product is a nondegradable soft tissue fastener. The recall covers specific lot numbers: 50478983, 50478986, 50478989, 50482871, 50484944, 50485587, and 50485589. The product was 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 facilities should check their inventory for these specific lot numbers and stop using the affected devices. Patients who have had this device implanted should contact their healthcare provider for guidance.

The recalled product

Product
SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
Category
Medical Device — Surgical Suture
Hazard
Affected units
1,086

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: 50478983
  • 50478986
  • 50478989
  • 50482871
  • 50484944
  • 50485587
  • 50485589

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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