Device product
Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
Z-0377-2019
Product summary
- Firm
- AROA BIOSURGERY
- Event
- Event 81161
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,853 total boxes
- Official record key
device-enforcement:Z-0377-2019
Official wording
Reason: Potential for pouch seal failure
Code information: Lot numbers: EDT-7H06 EDT-7L01 EDT-7L03 EDT-8A01
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Labeling or packaging
pouch seal failure