FDA Medical Device Recalls (openFDA)
AROA BIOSURGERY: 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.
- Recall number
- Z-0379-2019
- Recalling firm
- AROA BIOSURGERY
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-11-27
- Posted
- 2018-11-02
- Terminated
- 2019-04-09
- Reason
- Potential for pouch seal failure
- Root cause
- Employee error
- Action
- The firm sent a Customer Notification letter dated November 27, 2018. The letter identified the affected product, problem and actions to be taken. Customers are encouraged to visually inspect the seals on devices from these lots prior to use with particlar care. Should you observe a comprimised seal, please discard the device and select a new, fully sealed device for use.
- Quantity
- 8,853 total boxes
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot numbers: EDT-7I02 EDT-7L02
- 510(k) numbers
- ["K092096"]
- PMA numbers
- not on file
- Product code
- KGN
- Firm FEI
- 3007321028
- Firm city
- Airport Oaks
- Firm state
- not on file
- Firm country
- New Zealand
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28