Recall Z-1834-2016 ยท GET Motor, Surgical Instrument, Pneumatic Powered
MicroAire Surgical Instruments, LLC
Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
| Date | May 27, 2016 (initiated Mar 11, 2016) |
| Status | Terminated |
| 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 |
| Quantity | 20 units |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.