Z-0078-2019 Class II Terminated
FDA device recall Z-0078-2019 was initiated by Incisive Surgical Inc on August 29, 2018 and is designated Class II. Reason for recall: Possible compromise of the sterile barrier integrity The recall status is terminated (terminated March 18, 2019). Affected quantity: 1200 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2018
- Initiation Date
- August 29, 2018
- Termination Date
- March 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1200 units
Product Description
INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
Reason for Recall
Possible compromise of the sterile barrier integrity
Distribution Pattern
Israel
Code Information
UDI 10867516000101 Lot Number 182801