ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue defic...
FDA Device Recall #Z-0712-2018 — Class II — November 22, 2017
Recall Summary
| Recall Number | Z-0712-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 22, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Atrium Medical Corporation |
| Location | Merrimack, NH |
| Product Type | Devices |
| Quantity | 60 units |
Product Description
ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
Reason for Recall
An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.
Distribution Pattern
Internationally to Spain only.
Lot / Code Information
Product Code/REF 1010306-06 Lot Number/LOT: 412298
Other Recalls from Atrium Medical Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0024-2025 | Class II | iCast Covered Stent, 6MMx16MMx120CM, Model Numb... | Sep 9, 2024 |
| Z-1960-2024 | Class II | ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-End... | May 3, 2024 |
| Z-1951-2024 | Class II | ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-End... | May 3, 2024 |
| Z-1989-2024 | Class II | ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-End... | May 3, 2024 |
| Z-1954-2024 | Class II | ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-End... | May 3, 2024 |
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.