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

FDA Recall #Z-1466-2023 — Class II — April 10, 2023

Recall #Z-1466-2023 Date: April 10, 2023 Classification: Class II Status: Ongoing

Product Description

stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, 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

41 units

Distribution

US Nationwide distribution.

Code Information

UDI/DI 00889797101011, Lot Number 1736809

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated