Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical ...

FDA Device Recall #Z-1834-2016 — Class II — March 11, 2016

Recall Summary

Recall Number Z-1834-2016
Classification Class II — Moderate risk
Date Initiated March 11, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MicroAire Surgical Instruments, LLC
Location Charlottesville, VA
Product Type Devices
Quantity 20 units

Product Description

Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry

Reason for Recall

MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.

Distribution Pattern

United States

Lot / Code Information

2500-100 Ser#s 1547,1546,1545,1544, 1543,1542, 1541,1540,1539,1538,1537,1536,1535,1534,1533,1532 2500-200 Ser#s 1464,1463,1462,1461

Other Recalls from MicroAire Surgical Instruments, LLC

Recall # Classification Product Date
Z-1975-2025 Class II Brand Name: SmartRelease ESTR (Endoscopic soft ... May 7, 2025
Z-2222-2019 Class II SmartRelease Endoscopic Carpal Tunnel Release H... Jun 26, 2019
Z-2107-2018 Class II MicroAire SmartRelease Endoscopic System, Endos... Apr 19, 2018
Z-0412-2018 Class II SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, ... May 22, 2017
Z-1407-2017 Class II MicroAire K-Wires Feb 21, 2017

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.