ClearanceBrief
Recall Z-0078-2019 ยท GDW Staple, Implantable

Incisive Surgical Inc

INSORB SUBCUTICULAR SKIN STAPLER, REF 2030

DateAug 29, 2018
StatusTerminated
ReasonPossible compromise of the sterile barrier integrity
Root causeProcess control
ActionThe firm initiated the recall by telephone and email on 08/209/2018. The email notice requested that immediate suspension of all distribution. The firm will arrange to recover the product.
Quantity1200 units
DistributionIsrael
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K120373INSORB ABSORBALBE STAPLE
Incisive Surgical, Inc., Mar 16, 2012