FDA-Device2018-11-14Class II

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.

AROA BIOSURGERY
Hazard

Potential for pouch seal failure

Sold states
US Nationwide Distribution
Affected count
8,853 total boxes
Manufactured in
2 Kingsford Smith Place, Airport Oaks, New Zealand
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0377-2019

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