Z-2759-2016Class II

WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11...

Name: Z-2759-2016 WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11...
Creator: Teleflex Medical
Published: 2016-08-24
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2016-08-24 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck... on 2016-08-24. FDA classified it as Class II and gives the reason as "Misbranded: Incorrect etching on the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2759-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-24
Posted: 2016-09-08
Terminated: 2017-08-25
Recalling firm: Teleflex Medical
Product: WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as indicated. Applier color coding matches the color of the ligating clip cartridge for which it is to be used. Hemoclip Plus appliers are easily identified by one black-ring handle.
Product code: GDO Applier, Surgical, Clip
Reason for recall: Misbranded: Incorrect etching on the device.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Teleflex sent an Urgent Medical Device Notification letter dated August 24, 2016 to customers via FedEx. The letter identified the affected product, problem and actions to be taken. For questionscontact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 49 units
Distribution: Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.
Product codes and lots: Product Code: 337111, Lot Number: 06F1515745.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2759-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2759-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08

Product code GDO

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)