FDAClass IIOctober 17, 2018

Insorb Subcuticular Skin Stapler recall: Sterility Concern

INSORB SUBCUTICULAR SKIN STAPLER, REF 2030

Why was Insorb Subcuticular Skin Stapler recalled?

Possible compromise of the sterile barrier integrity

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI 10867516000101 Lot Number 182801

Product
INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
Recalling firm
Incisive Surgical Inc
Quantity
1200 units
Distribution
Israel
Recall date
October 17, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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