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Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile...

FDA Recall #Z-0377-2019 — Class II — November 27, 2018

Recall #Z-0377-2019 Date: November 27, 2018 Classification: Class II Status: Terminated

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

Recalling Firm

AROA BIOSURGERY — Airport Oaks

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

8,853 total boxes

Distribution

US Nationwide Distribution

Code Information

Lot numbers: EDT-7H06 EDT-7L01 EDT-7L03 EDT-8A01

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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