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Terminated

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.

FDA Recall Z-1545-2015 · Posted 2015-04-29

Recalling FirmIncisive Surgical Inc
Recall StatusTerminated
Product CodeGDW
Date Initiated2015-03-19
Date Terminated2015-07-08
Product Quantity210 cartons (containing 6 INSORB staplers per carton)

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.

Firm Action

Firm is working with EU Rep on English and Turkish notification letters.

Root Cause

Labeling False and Misleading

Distribution Pattern

International Distribution Only - Turkey.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120373INSORB ABSORBALBE STAPLEIncisive Surgical, Inc. · 2012-03-16K090159INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIESIncisive Surgical, Inc. · 2009-02-06K061784INSORB ABSORBABLE STAPLE, MODEL 1020Incisive Surgical, Inc. · 2006-07-26K033602INSORB ABSORBABLE STAPLE, MODEL SP-B20Incisive Surgical, Inc. · 2003-12-16K024117INSORB ABSORBABLE STAPLES, MODEL SP-B20Incisive Surgical, Inc. · 2003-04-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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