Smith & Nephew, Inc. Endoscopy Division: Medical Device Recall in 2014 - (Recall #: Z-2048-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue

Product Classification:

Class II

Date Initiated: June 2, 2014

Date Posted: July 23, 2014

Recall Number: Z-2048-2014

Event ID: 68565

Reason for Recall:

Sterility of device is compromised due to breach in sterile barrier

Status: Terminated

Product Quantity: 1086 untis

Code Information:

Lot Numbers: 50478983, 50478986, 50478989, 50482871, 50484944, 50485587, 50485589

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated