Z-0379-2019 Class II Terminated
FDA device recall Z-0379-2019 was initiated by AROA BIOSURGERY on Nov 27, 2018 and is designated Class II. Reason for recall: Potential for pouch seal failure The recall status is terminated (terminated Apr 9, 2019). Affected quantity: 8,853 total boxes.
Recall details
- Product Type
- Devices
- Report Date
- Nov 14, 2018
- Initiation Date
- Nov 27, 2018
- Termination Date
- Apr 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,853 total boxes
Product description
Endoform Dermal Template 4x5, SKU 529313 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 for recall
Potential for pouch seal failure
Distribution pattern
US Nationwide Distribution
Code information
Lot numbers: EDT-7I02 EDT-7L02
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0379-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026