FDA-Device2018-05-16Class II

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.

DePuy Mitek, Inc., a Johnson & Johnson Co.
Hazard

Reports of product loosening or coming unscrewed from the handle.

Sold states
US Nationwide Distribution in the states of OH, WA, CO
Affected count
84
Manufactured in
325 Paramount Dr, N/A, Raynham, MA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1749-2018

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