FDA recall Z-1536-2018

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-12-11

Report date

2018-05-02

Termination date

2020-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1536-2018