Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile...
FDA Device Recall #Z-0378-2019 — Class II — November 27, 2018
Recall Summary
| Recall Number | Z-0378-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 27, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | AROA BIOSURGERY |
| Location | Airport Oaks |
| Product Type | Devices |
| Quantity | 8,853 total boxes |
Product Description
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.
Reason for Recall
Potential for pouch seal failure
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
Lot numbers: EDT-7I01 EDT-7K01 EDT-7L05
Other Recalls from AROA BIOSURGERY
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0377-2019 | Class II | Endoform Dermal Template 2x2, SKU 529311 Pro... | Nov 27, 2018 |
| Z-0379-2019 | Class II | Endoform Dermal Template 4x5, SKU 529313 Pro... | Nov 27, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.