FDA-Device2015-05-06Class II
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.
Incisive Surgical Inc
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.
Sold states
International Distribution Only - Turkey.
Affected count
210 cartons (containing 6 INSORB staplers per carton)
Manufactured in
14405 21st Ave N, Plymouth, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1545-2015Don't want to check this manually?
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