Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limit...

FDA Device Recall #Z-0740-2022 — Class II — January 13, 2022

Recall Summary

Recall Number Z-0740-2022
Classification Class II — Moderate risk
Date Initiated January 13, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Nextremity Solutions
Location Warsaw, IN
Product Type Devices
Quantity 24 units

Product Description

Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT

Reason for Recall

During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision

Distribution Pattern

US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.

Lot / Code Information

Lot Numbers: 1574701, 158961 UDI: 00817701026372

Other Recalls from Nextremity Solutions

Recall # Classification Product Date
Z-0911-2022 Class II Nextra Hammertoe Correction System 4.5 Middle a... Feb 10, 2022
Z-0910-2022 Class II Nextra Hammertoe Correction System 4.5 Middle 3... Feb 10, 2022
Z-0912-2022 Class II Nextra Hammertoe Correction System 3.5 Middle 3... Feb 10, 2022
Z-0914-2022 Class II Nextra Hammertoe Correction System Driver SKU... Feb 10, 2022
Z-0913-2022 Class II Nextra Hammertoe Correction System 3.5 Middle a... Feb 10, 2022

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.