Device 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.
Z-1545-2015
Product summary
- Event
- Event 70906
- Status
- Terminated
- Classification
- Class II
- Quantity
- 210 cartons (containing 6 INSORB staplers per carton)
- Official record key
device-enforcement:Z-1545-2015
Official wording
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.
Code information: Lot 121901
Distribution pattern: International Distribution Only - Turkey.
Derived failure modes
-
Unknown
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.