FDA Medical Device Recalls (openFDA)
MicroAire Surgical Instruments, LLC: Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
- Recall number
- Z-1834-2016
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Product
- Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
- Status
- Terminated
- Initiated
- 2016-03-11
- Posted
- 2016-05-27
- Terminated
- 2017-02-14
- Reason
- 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.
- Root cause
- 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
- 20 units
- Distribution
- United States
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GET
- Firm FEI
- 2020601
- Firm city
- Charlottesville
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28