Z-2108-2017Class II

WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the...

Name: Z-2108-2017 WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the...
Creator: Teleflex Medical
Published: 2017-03-24
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2017-03-24 / Completed / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer... on 2017-03-24. FDA classified it as Class II and gives the reason as "Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2108-2017
Classification: Class II
Status: Completed
Initiated: 2017-03-24
Posted: 2017-05-17
Recalling firm: Teleflex Medical
Product: WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures
Product code: GDT Staple, Removable (Skin)
Reason for recall: Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Teleflex sent an Urgent Medical Device Correction Notice dated March 24, 2017, to consignees. The letter requested that they check inventory on hand and quarantine product for return. They letter also requested that distributors conduct a sub-recall. The letter included a reply form to be returned. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 3594 eaches
Distribution: Worldwide Distribution - US including CA, FL, GA, IL, IN, KS, KY, ME, MD, MA, MI, NJ, NY, NC, OH, OR, RI, TX, UT, VA, and Internationally to Australia, Belgium and France
Product codes and lots: 73H1600207

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2108-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2108-2017	Class II	Completed	Voluntary: Firm initiated	2017-05-24	2017-05-17

Product code GDT

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)