Recall Z-1545-2015 ยท GDW Staple, Implantable
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.
| Date | Apr 29, 2015 (initiated Mar 19, 2015) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024117 | INSORB ABSORBABLE STAPLES, MODEL SP-B20 Incisive Surgical, Inc., Apr 22, 2003 |
| K033602 | INSORB ABSORBABLE STAPLE, MODEL SP-B20 Incisive Surgical, Inc., Dec 16, 2003 |
| K061784 | INSORB ABSORBABLE STAPLE, MODEL 1020 Incisive Surgical, Inc., Jul 26, 2006 |
| K090159 | INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES Incisive Surgical, Inc., Feb 6, 2009 |
| K120373 | INSORB ABSORBALBE STAPLE Incisive Surgical, Inc., Mar 16, 2012 |