Recall Z-0377-2019— AROA BIOSURGERY
Class II · Terminated
Class II FDA medical device recall by AROA BIOSURGERY, initiated 2018-11-27, terminated 2019-04-09. It names one FDA 510(k) clearance: K092096. 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.. Reason: Potential for pouch seal failure.
- Recalling firm
- AROA BIOSURGERY
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-27
- Terminated
- 2019-04-09
- Firm location
- Airport Oaks, New Zealand
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Potential for pouch seal failure
Data sourced from openFDA. This site is unofficial and independent of the FDA.