Smith & Nephew, Inc. Endoscopy Division: Medical Device Recall in 2014 - (Recall #: Z-2049-2014)

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 Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue

Product Classification:

Class II

Date Initiated: June 2, 2014

Date Posted: July 23, 2014

Recall Number: Z-2049-2014

Event ID: 68565

Reason for Recall:

Sterility of device is compromised due to breach in sterile barrier

Status: Terminated

Product Quantity: 763 units

Code Information:

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

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