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Class 2 Device Recall MicroAire Pneumatic Impactor |
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Date Initiated by Firm |
March 11, 2016 |
Date Posted |
May 27, 2016 |
Recall Status1 |
Terminated 3 on February 14, 2017 |
Recall Number |
Z-1834-2016 |
Recall Event ID |
73661 |
Product Classification |
Motor, surgical instrument, pneumatic powered - Product Code GET
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Product |
Pneumatic Impactor, General Surgery, With Microaire Hose Connector
Professional Use, Medical Industry |
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 |
Recalling Firm/ Manufacturer |
MicroAire Surgical Instruments, LLC 3590 Grand Forks Blvd Charlottesville VA 22911-9006
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For Additional Information Contact |
434-975-8000
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Manufacturer 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.
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FDA Determined Cause 2 |
Other |
Action |
MicroAire sent an Urgent Medical Device Recall letter dated March 28, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
We request that you please respond to this letter promptly to determine how many of these units you have and will be returning to MicroAire. Upon return of the instrument to MicroAire, MicroAire will provide you with replacements.
Please complete and send back to MicroAire page two of this letter, indicating that you do have this instrument at your facility and whether you will be returning the instrument for replacement.
You can email the form to MicroAire Customer Service at notification@microaire.com or fax the form to 1-800-648-4309.
You can contact MicroAire Customer Service at 1-800-722-0822 in the United States or 1-434-975-8000 outside the United States, between the hours of 8:30 AM and 5:30 PM (ET) Monday through Friday if you have any questions. |
Quantity in Commerce |
20 units |
Distribution |
United States |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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