Z-1834-2016Class II

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

Name: Z-1834-2016 Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
Creator: MicroAire Surgical Instruments, LLC
Published: 2016-03-11
License: https://open.fda.gov/license/

MicroAire Surgical Instruments, LLC / initiated 2016-03-11 / Terminated

FDA source

MicroAire Surgical Instruments, LLC began a recall of Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry on 2016-03-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1834-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-11
Posted: 2016-05-27
Terminated: 2017-02-14
Recalling firm: MicroAire Surgical Instruments, LLC
Product: Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
Product code: GET Motor, Surgical Instrument, Pneumatic Powered
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.
FDA 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 [email protected] 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1834-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1834-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-27

Product code GET

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)