Z-0078-2019Class II

Insorb Subcuticular Skin Stapler, Ref 2030

Name: Z-0078-2019 Insorb Subcuticular Skin Stapler, Ref 2030
Creator: Incisive Surgical Inc
Published: 2018-08-29
License: https://open.fda.gov/license/

Incisive Surgical, Inc. / initiated 2018-08-29 / Terminated / root cause: manufacturing process

FDA source

Incisive Surgical Inc began a recall of INSORB SUBCUTICULAR SKIN STAPLER, REF 2030 on 2018-08-29. FDA classified it as Class II and gives the reason as "Possible compromise of the sterile barrier integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0078-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-29
Posted: 2018-10-05
Terminated: 2019-03-18
Recalling firm: Incisive Surgical, Inc.
Product: Insorb Subcuticular Skin Stapler, Ref 2030
Product code: GDW Staple, Implantable
Reason for recall: Possible compromise of the sterile barrier integrity
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by telephone and email on 08/209/2018. The email notice requested that immediate suspension of all distribution. The firm will arrange to recover the product.
Quantity in commerce: 1200 units
Distribution: Israel
Product codes and lots: UDI 10867516000101 Lot Number 182801

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0078-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0078-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-05

Product code GDW

K120373Class IIInsorb Absorbalbe StapleIncisive Surgical, Inc. / cleared 2012-03-16

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)