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Recall Observatory FDA recall evidence

Device product

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

Z-1834-2016

March 11, 2016

Class II

Product summary

Firm
MicroAire Surgical Instruments, LLC
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

    reason.no_named_rule · v1.0.0

    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.