Recall Z-1545-2015— Incisive Surgical Inc

Name: FDA recall Z-1545-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-19

Class II · Terminated

Class II FDA medical device recall by Incisive Surgical Inc, initiated 2015-03-19, terminated 2015-07-08. It names 5 FDA 510(k) clearances: K120373, K090159, K061784 and 2 more. 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.. Reason: 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..

Recalling firm: Incisive Surgical Inc
Classification: Class II
Status: Terminated
Initiated: 2015-03-19
Terminated: 2015-07-08
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

5 on FDA's record

K120373 — INSORB ABSORBALBE STAPLEIncisive Surgical, Inc.·cleared 2012-03-16
K090159 — INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIESIncisive Surgical, Inc.·cleared 2009-02-06
K061784 — INSORB ABSORBABLE STAPLE, MODEL 1020Incisive Surgical, Inc.·cleared 2006-07-26
K033602 — INSORB ABSORBABLE STAPLE, MODEL SP-B20Incisive Surgical, Inc.·cleared 2003-12-16
K024117 — INSORB ABSORBABLE STAPLES, MODEL SP-B20Incisive Surgical, Inc.·cleared 2003-04-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.