Medical device recalls Moderate risk

DePuy Mitek, Inc., a Johnson & Johnson Co. recalls LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended t…

Recall date
December 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1749-2018
FDA classification
Class II
Brand / firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Sold / distributed
US Nationwide Distribution in the states of OH, WA, CO

Why it was recalled

Reports of product loosening or coming unscrewed from the handle.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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