Z-1834-2019Class II

Signia Tri-Staple 2.0 Black 60Mm Extra Thick Reloa, Sig60axt

Name: Z-1834-2019 Signia Tri-Staple 2.0 Black 60Mm Extra Thick Reloa, Sig60axt
Creator: Covidien LLC
Published: 2019-05-17
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-05-17 / Open, Classified / root cause: manufacturing process

FDA source

Covidien LLC began a recall of SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT on 2019-05-17. FDA classified it as Class II and gives the reason as "The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which...". 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-1834-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-05-17
Posted: 2019-06-16
Recalling firm: Medtronic, Inc.
Product: Signia Tri-Staple 2.0 Black 60Mm Extra Thick Reloa, Sig60axt
Product code: GDW Staple, Implantable
Reason for recall: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All consignees were notified by letter delivered via Federal Express and/or certified mail beginning May 17, 2019. The letter informs customers of the recall of specific item codes and production lots of Covidien Endo GIA Articulating Reloads with Tri-Staple Technology due to the potential for a device to be missing one of two pin components that maintain alignment of the device jaws. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item codes and lots. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Endo GIA" Articulating Reloads with Tri-Staple Technology. " Complete the Recalled Product Return Form. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in commerce: 3,113,280
Distribution: Nationwide domestic distribution, worldwide foreign distribution.
Product codes and lots: N6C0533UX N6C0582UX N6C0657UX N6C0681UX N6E0115UX N6E0116UX N6E0976UX N6E0977UX N6E0978UX N6E0979UX N6F0045UX N6F0046UX N6F0047UX N6F0048UX N6F0049UX N6F0050UX N6F0295UX N6F0503UX N6F0504UX N6F0505UX N6F0506UX N6F0507UX N6F0508UX N6F0509UX N6F0748UX N6F0758UX N6F0759UX N6F0760UX N6F0786UX N6F0787UX N6F0788UX N6G0068UX N6G0270UX N6G0271UX N6G0287UX N6G0288UX N6G0486UX N6G0499UX N6G0784UX N6G0785UX N6G0786UX N6H0105UX N6H0106UX N6H0107UX N6H0155UX N6H0156UX N6H0157UX N6H0173UX N6H0174UX N6H0298UX N6H0299UX N6H0302UX N6H0522UX N6H0693UX N6H0734UX N6H0909UX N6H0946UX N6J0040UX N6J0092UX N6K0302UX N6K0970UX N6K1067UX N6L0152UX N6M0328UX N7A0170UX N7C0475X N7C1091X N7C1092X N7D0104X N8A0087X N8D0035X N8D0225X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1834-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1825-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1826-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1827-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1828-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1829-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1830-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1831-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1832-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1833-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1834-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1835-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1836-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15

Product code GDW

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)