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Recall Observatory FDA recall evidence

Device product

stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation

Z-1466-2023

April 10, 2023

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 92078
Status
Ongoing
Classification
Class II
Quantity
41 units
Official record key
device-enforcement:Z-1466-2023

Official wording

Reason: Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.

Code information: UDI/DI 00889797101011, Lot Number 1736809

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.