Device product
Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
Z-1834-2016
Product summary
- Event
- Event 73661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1834-2016
Official wording
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.
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
Distribution pattern: United States
Derived failure modes
-
Unknown
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.