Smith & Nephew, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1536-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015

Product Classification:

Class II

Date Initiated: December 11, 2017

Date Posted: May 2, 2018

Recall Number: Z-1536-2018

Event ID: 79700

Reason for Recall:

Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.

Status: Terminated

Product Quantity: 22

Code Information:

Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355

Distribution Pattern:

Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.

Voluntary or Mandated:

Voluntary: Firm initiated