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Recall Observatory FDA recall evidence

Device product

SMR allen wrench 5 mm, product code 9013.50.210

Z-2707-2016

July 21, 2016

Class II

Product summary

Firm
Limacorporate S.p.A
Event
Event 74827
Status
Terminated
Classification
Class II
Quantity
76
Official record key
device-enforcement:Z-2707-2016

Official wording

Reason: Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles.

Code information: 14AA311

Distribution pattern: US, Italy, Australia

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles.