Z-0379-2019 Class II Terminated
FDA device recall Z-0379-2019 was initiated by AROA BIOSURGERY on November 27, 2018 and is designated Class II. Reason for recall: Potential for pouch seal failure The recall status is terminated (terminated April 9, 2019). Affected quantity: 8,853 total boxes.
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2018
- Initiation Date
- November 27, 2018
- Termination Date
- April 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