Z-1011-2019Class II

US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in...

Name: Z-1011-2019 US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in...
Creator: US Endoscopy Group Inc
Published: 2019-02-04
License: https://open.fda.gov/license/

United States Endoscopy Group, Inc. / initiated 2019-02-04 / Terminated / root cause: design

FDA source

US Endoscopy Group Inc began a recall of US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in... on 2019-02-04. FDA classified it as Class II and gives the reason as "Potential esophageal laceration during a patient procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1011-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-04
Posted: 2019-03-13
Terminated: 2020-08-03
Recalling firm: United States Endoscopy Group, Inc.
Product: US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
Product code: PKL Hemostatic Metal Clip For The Gi Tract
Reason for recall: Potential esophageal laceration during a patient procedure
Root cause tag: design
FDA root cause: Device Design
Action: The firm, US Endoscopy issued a Recall Notification Letter entitled "URGENT VOLUNTARY RECALL NOTICE" and dated 2/1/19 on 2/4/19 to Customers who purchased affected lots of the Padlock Defect closure system. The Recall Notification Letter was sent to domestic Customers via FedEx with delivery confirmation receipt. Affected international distributors issued Recall Notification Letter via email. Letter identifies the product, problem, and actions to take. The customer were instructed to do the following: 1. Quarantine affected Padlock Clip defect closure systems (C910001 ). 2. Complete the Medical Device Recall Response Card included with this Customer Notification Letter. Your US Endoscopy Product Specialist can assist should you have any questions while completing the Card. 3. Return the completed Medical Device Recall Response Card via email to: [email protected] or via fax to 440-639-4495. If you have any questions regarding this matter, please call: 440-392-7633.
Quantity in commerce: 483 units ( 325 units US and 158 OUS)
Distribution: Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Czech Republic, Germany, Great Britain, India, Italy, Lebanon, Mexico, Netherlands, Norway, Philippines, S. Korea, Spain, Sweden and United Arab Emirates.
Product codes and lots: Lot Numbers: 1814568, 1814569, 1815200, 1815592, 1816056, 1817174, 1817810, 1818187, 1818596, 1819180, 1819181, 1819407, 1819793, and 1820177.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1011-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1011-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-13

Product code PKL

K120814Class IIPadlock Clip-12Aponos Medical Corp. / cleared 2012-09-06

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)