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Recall Observatory FDA recall evidence

Device product

MOUSE 9732721 STERILE O-ARM 10PK

Z-1588-2014

April 24, 2014

Class II

Product summary

Firm
Medtronic Navigation, Inc.
Event
Event 68145
Status
Terminated
Classification
Class II
Quantity
26,674 total
Official record key
device-enforcement:Z-1588-2014

Official wording

Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

Code information: Lot No.: 5051140611 5336060213 5162060112 4734921009

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.