FDA Medical Device Recalls (openFDA)
Incisive Surgical Inc: 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 number
- Z-1545-2015
- Recalling firm
- Incisive Surgical Inc
- 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.
- Status
- Terminated
- Initiated
- 2015-03-19
- Posted
- 2015-04-29
- Terminated
- 2015-07-08
- 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.
- Root cause
- Labeling False and Misleading
- Action
- Firm is working with EU Rep on English and Turkish notification letters.
- Quantity
- 210 cartons (containing 6 INSORB staplers per carton)
- Distribution
- International Distribution Only - Turkey.
- Lot, serial or model codes
- Lot 121901
- 510(k) numbers
- ["K024117","K033602","K061784","K090159","K120373"]
- PMA numbers
- not on file
- Product code
- GDW
- Firm FEI
- 3004028675
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28