stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
FDA Recall #Z-1467-2023 — Class II — April 10, 2023
Product Description
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Reason for Recall
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
Recalling Firm
Wright Medical Technology, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
50 units
Distribution
US Nationwide distribution.
Code Information
UDI/DI 00889797101035, Lot Number 1737413
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated