CLASS II Device recall · Reported 6 May 2015 · FDA Enforcement Report

Insorb Subcuticular Skin Stapler recalled by Incisive Surgical

Incisive Surgical is recalling Insorb Subcuticular Skin Stapler, distributed nationwide in the US. The recall was initiated on 19 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 121901

Quantity recalled210 cartons (containing 6 INSORB staplers per carton)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1545-2015
FDA event ID: 70906
Recalling firm: Incisive Surgical, Plymouth, MN
Classification: Class II
Status: Terminated
Recall initiated: 19 Mar 2015
FDA classified: 29 Apr 2015
Reported: 6 May 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

19 Mar 2015	Recall initiated by company
29 Apr 2015	Classified by FDA	+41 days
6 May 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

International Distribution Only - Turkey.

Nationwide

Questions about this recall

Is Insorb Subcuticular Skin Stapler recalled?

Yes. Incisive Surgical recalled Insorb Subcuticular Skin Stapler on 19 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1545-2015.

Why was it recalled?

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.

Which lots are affected?

Lot 121901

Where was it sold?

International Distribution Only - Turkey.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Incisive Surgical

All 2

Reported	Class	Recall	Company	Reason	Where
17 Oct 2018Device	CLASS II	Insorb Subcuticular Skin Stapler recalled by Incisive Surgical	Incisive Surgical	Sterility	MN

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