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Recall Observatory FDA recall evidence

Device product

Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600

Z-2073-2017

April 11, 2017

Class II

Product summary

Firm
Biomet Microfixation, LLC
Event
Event 77022
Status
Terminated
Classification
Class II
Quantity
33 units
Official record key
device-enforcement:Z-2073-2017

Official wording

Reason: Part of the number on the tray lid differ from the part number on the base.

Code information: Part Number 46-1610 // Lot Number 709730 Part Number 46-1610 // Lot Number 709740 Part Number 46-1620 // Lot Number 709710 Part Number 46-1620 // Lot Number 709720

Distribution pattern: AL, MO and UT Canada, Australia, Netherlands, and Egypt

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Part of the number on the tray lid differ from the part number on the base.