Incisive Surgical Inc: Medical Device Recall in 2015 - (Recall #: Z-1545-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 19, 2015

Date Posted: May 6, 2015

Recall Number: Z-1545-2015

Event ID: 70906

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.

Status: Terminated

Product Quantity: 210 cartons (containing 6 INSORB staplers per carton)

Code Information:

Lot 121901

Distribution Pattern:

International Distribution Only - Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated