Z-1545-2015Class II

Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic...

Name: Z-1545-2015 Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic...
Creator: Incisive Surgical Inc
Published: 2015-03-19
License: https://open.fda.gov/license/

Incisive Surgical, Inc. / initiated 2015-03-19 / Terminated / root cause: labeling and UDI

FDA source

Incisive Surgical Inc began a recall of Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids... on 2015-03-19. FDA classified it as Class II and gives the reason as "A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expiration date at the time of manufacturing was 2014-05". 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-1545-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-19
Posted: 2015-04-29
Terminated: 2015-07-08
Recalling firm: Incisive Surgical, Inc.
Product: Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.
Product code: GDW Staple, Implantable
Reason for recall: A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expiration date at the time of manufacturing was 2014-05.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Firm is working with EU Rep on English and Turkish notification letters.
Quantity in commerce: 210 cartons (containing 6 INSORB staplers per carton)
Distribution: International Distribution Only - Turkey.
Product codes and lots: Lot 121901

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1545-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1545-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)