Z-0378-2019Class II

Endoform Dermal Template 2x2, SKU 529312

Name: Z-0378-2019 Endoform Dermal Template 2x2, SKU 529312
Creator: Aroa Biosurgery
Published: 2018-11-27
License: https://open.fda.gov/license/

AROA Biosurgery Inc. / initiated 2018-11-27 / Terminated / root cause: manufacturing process

FDA source

AROA BIOSURGERY began a recall of Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix... on 2018-11-27. FDA classified it as Class II and gives the reason as "Potential for pouch seal failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0378-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-27
Posted: 2018-11-02
Terminated: 2019-04-09
Recalling firm: AROA Biosurgery Inc.
Product: Endoform Dermal Template 2x2, SKU 529312 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.
Product code: KGN Wound Dressing With Animal-Derived Material(S)
Reason for recall: Potential for pouch seal failure
Root cause tag: manufacturing process
FDA 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 in commerce: 8,853 total boxes
Distribution: US Nationwide Distribution
Product codes and lots: Lot numbers: EDT-7I01 EDT-7K01 EDT-7L05

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0378-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0377-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-02
Z-0378-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-02
Z-0379-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-02

Product code KGN

K092096UnclassifiedEndoform Dermal TemplateMesynthes, Ltd. / cleared 2010-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)