'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers:...

FDA Device Recall #Z-1824-2023 — Class II — July 23, 2019

Recall Summary

Recall Number Z-1824-2023
Classification Class II — Moderate risk
Date Initiated July 23, 2019
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm New Standard Device Inc
Location San Antonio, TX
Product Type Devices
Quantity 222 units

Product Description

'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

Reason for Recall

The threads on posts stripping out when tensioned during application process.

Distribution Pattern

U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.

Lot / Code Information

Catalog Numbers / Lot Numbers: 100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 / A29318U 100805 / A29318V UDI Codes: Not provided/None

Other Recalls from New Standard Device Inc

Recall # Classification Product Date
Z-1649-2022 Class II Metalogix Self-Drill Half-Pin, a component of t... Dec 28, 2020
Z-1236-2022 Class II 1.8mm Truss Wire, REF: 900217, a Component of M... Jun 8, 2020
Z-1280-2022 Class II Metalogix Slotted 90 Tubular Wrench x 10mm REF ... Aug 14, 2019

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.