Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblo...
FDA Device Recall #Z-2761-2016 — Class II — August 5, 2016
Recall Summary
| Recall Number | Z-2761-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 5, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Riverpoint Medical, LLC |
| Location | Portland, OR |
| Product Type | Devices |
| Quantity | 2110 boxes distributed in the US and 72 boxes distributed outside US |
Product Description
Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
Reason for Recall
Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
Distribution Pattern
US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.
Lot / Code Information
Lot For human use: 160210-02. Lots For Vet use: 160223-03V 160302-06V 160202-01V 160217-02V 160224-03V 160218-03V 160204-01
Other Recalls from Riverpoint Medical, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0518-2024 | Class II | Iconix Knotless 1.4mm Anchor with XBraid S (Bl... | Oct 25, 2023 |
| Z-0949-2021 | Class II | Covidien CV-9590 Velosorb Fast Braided Fast abs... | Dec 9, 2020 |
| Z-0031-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Cov... | Aug 3, 2020 |
| Z-0046-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Cov... | Aug 3, 2020 |
| Z-0020-2021 | Class II | Velosorb Fast Braided Absorbable Suture: Cov... | Aug 3, 2020 |
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.