FDA Recall
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.
Recall: Z-1545-2015
·
Initiated March 19, 2015
Recall
- Recall Number
- Z-1545-2015
- Event Number
- 70906
- Firm
- Incisive Surgical Inc
- FEI Number
- 3004028675
- Product Code
- GDW
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- March 19, 2015
- Posted
- April 29, 2015
- Terminated
- July 8, 2015
- Address
- 14405 21st Ave N, Plymouth, MN, 55447-4685
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
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.
Action
Firm is working with EU Rep on English and Turkish notification letters.
Distribution
International Distribution Only - Turkey.
Quantity
210 cartons (containing 6 INSORB staplers per carton)