Incisive Surgical Inc recalls Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester d…

Recall date

March 19, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1545-2015

FDA classification

Class II

Brand / firm

Incisive Surgical Inc

Sold / distributed

International Distribution Only - Turkey.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.