Z-0764-2017Class II

WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of...

Name: Z-0764-2017 WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of...
Creator: Teleflex Medical
Published: 2016-11-18
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2016-11-18 / Terminated / root cause: packaging

FDA source

Teleflex Medical began a recall of WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on... on 2016-11-18. FDA classified it as Class II and gives the reason as "Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0764-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-18
Posted: 2016-12-14
Terminated: 2017-11-24
Recalling firm: Teleflex Medical
Product: WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close 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: Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm, Telexflex Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 11/18/2016 to its Consignees/Customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any affected products; complete and return the Recall Acknowledgement Form by fax to 1-855-419-8507, Attn: Customer Service or email to: [email protected] (even if you do not have any affected product) and return the product with the completed Recall Acknowledgement Form. A customer service representative will contact you with a RGA # and provide instructions for the return of the product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 96,402 units (9,120 ea US, 87,282 ea OUS)
Distribution: Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.
Product codes and lots: Product Code: 528235, Lot numbers: 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006 and 73M1500130.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0764-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0764-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-14

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)