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Incisive Surgical Inc recalls Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester d
Recalled May 6, 2015 · FDA recall Z-1545-2015 · Incisive Surgical
Hazard
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. · FDA Class II
Units
210 cartons (containing 6 INSORB staplers per carton)
Sold at
International Distribution Only - Turkey.
Description
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
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.
Manufacturer(s)
Incisive Surgical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →