Z-0759-2017Class II

Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and...

Name: Z-0759-2017 Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and...
Creator: Teleflex Medical
Published: 2016-11-16
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2016-11-16 / Terminated

FDA source

Teleflex Medical began a recall of Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites on 2016-11-16. FDA classified it as Class II and gives the reason as "The devices wings may become partially detached from the EFx Shield during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0759-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-16
Posted: 2016-12-14
Terminated: 2017-12-13
Recalling firm: Teleflex Medical
Product: Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
Product code: HCF Instrument, Ligature Passing And Knot Tying
Reason for recall: The devices wings may become partially detached from the EFx Shield during use.
FDA root cause: Other
Action: Consignees were notified via letter on 11/16/2016.
Quantity in commerce: 2265 units
Distribution: Domestic; US Nationwide; International: Belgium, Canada.
Product codes and lots: Product Code: EFX002, Lot numbers: 3264480000, 3269990000, 3270100000.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0759-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0759-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-14

Product code HCF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)