LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability ...
FDA Recall #Z-1749-2018 — Class II — December 22, 2017
Product Description
LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries.
Reason for Recall
Reports of product loosening or coming unscrewed from the handle.
Recalling Firm
DePuy Mitek, Inc., a Johnson & Johnson Co. — Raynham, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
84
Distribution
US Nationwide Distribution in the states of OH, WA, CO
Code Information
16D01,16D02, 16K01, 17A01, 17B01, 17B02
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated