PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 16, 2018 Initiated: December 22, 2017 #Z-1749-2018

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.

Details

Units Affected
84
Distribution
US Nationwide Distribution in the states of OH, WA, CO
Location
Raynham, MA

Frequently Asked Questions

What product 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.. Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co.. Units affected: 84.
Why was this product recalled?
Reports of product loosening or coming unscrewed from the handle.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1749-2018.