FDA Device recall Z-0378-2019
Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extrace…
- FDA Device
- Class II
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class II recall of Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extrace… by Aroa Biosurgery, citing potential for pouch seal failure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0378-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-27 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Aroa Biosurgery |
| Distribution | US |
Product
Endoform Dermal Template 2x2, SKU 529312 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.
Reason
Potential for pouch seal failure
Identifiers
| code_info | Lot numbers: EDT-7I01 EDT-7K01 EDT-7L05 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0378-2019%22
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