Z-2507-2018Class II

Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code...

Name: Z-2507-2018 Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code...
Creator: Covidien Medtronic
Published: 2018-05-22
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-05-22 / Open, Classified / root cause: manufacturing process

FDA source

COVIDIEN MEDTRONIC began a recall of Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT on 2018-05-22. FDA classified it as Class II and gives the reason as "Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2507-2018
Classification: Class II
Status: Open, Classified
Initiated: 2018-05-22
Posted: 2018-07-19
Recalling firm: Medtronic, Inc.
Product: Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT
Product code: GDW Staple, Implantable
Reason for recall: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 22, 2018, all U.S. consignees received an UPDATED URGENT MEDICAL DEVICE RECALL and RETURN FORM notice via Federal Express or certified. The initial notice was sent to impacted customers on April 26, 2018. Customers are advised to take the following required actions: 1. Immediately discontinue use, and quarantine affected products listed 2. Return affected product as indicated. 3. Complete the Recalled Product Return Form even if you do not have inventory and submit by either method below: * Product purchased directly from Medtronic: [email protected] or fax to (800) 895-6140. *Product purchased through distributor: [email protected] or fax it to (203) 492-7719.
Distribution: Nationwide U.S.A. Internationally to: Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta, Martinique, Moldova, Morocco, Namibia, Netherlands, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates & United Kingdom
Product codes and lots: N7L0852X, N7M0130X, N8A0145X, N8A0336X, N7L0931X, N7M0639X, N8A0796X & N8B0993X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2507-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2503-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19
Z-2504-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19
Z-2505-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19
Z-2506-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19
Z-2507-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19
Z-2508-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19
Z-2509-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19
Z-2510-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19
Z-2511-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19
Z-2512-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19
Z-2513-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19
Z-2514-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19
Z-2515-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19
Z-2516-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-07-25	2018-07-19

Product code GDW

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)