FDA recall Z-0078-2019
Incisive Surgical Inc · Class II · device
Product
INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
Reason for recall
Possible compromise of the sterile barrier integrity
Distribution
Israel
Key facts
- Status
- Terminated
- Initiation date
- 2018-08-29
- Report date
- 2018-10-17
- Termination date
- 2019-03-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Plymouth, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0078-2019