FDA recall Z-1749-2018

Product

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.

Distribution

US Nationwide Distribution in the states of OH, WA, CO

Key facts

Status

Terminated

Initiation date

2017-12-22

Report date

2018-05-16

Termination date

2019-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raynham, MA, United States

Primary source

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