ClearanceBrief
Recall Z-0759-2017 ยท HCF Instrument, Ligature Passing And Knot Tying

Teleflex Medical

Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

DateNov 16, 2016
StatusTerminated
ReasonThe devices wings may become partially detached from the EFx Shield during use.
Root causeOther
ActionConsignees were notified via letter on 11/16/2016.
Quantity2265 units
DistributionDomestic; US Nationwide; International: Belgium, Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.