Z-1545-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2015
- Initiation Date
- March 19, 2015
- Termination Date
- July 8, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 210 cartons (containing 6 INSORB staplers per carton)
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.
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.
Distribution Pattern
International Distribution Only - Turkey.
Code Information
Lot 121901