FDAClass IIMay 6, 2015

Insorb Subcuticular Skin Stapler. INSORB staples are recall

Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic…

Why was Insorb Subcuticular Skin Stapler. INSORB staples are 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.

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?

Lot 121901

Product
Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic…
Recalling firm
Incisive Surgical Inc
Quantity
210 cartons (containing 6 INSORB staplers per carton)
Distribution
International Distribution Only - Turkey.
Recall date
May 6, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls