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Recall Observatory FDA recall evidence

Device 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.

Z-1749-2018

December 22, 2017

Class II

Product summary

Firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Event
Event 79518
Status
Terminated
Classification
Class II
Quantity
84
Official record key
device-enforcement:Z-1749-2018

Official wording

Reason: Reports of product loosening or coming unscrewed from the handle.

Code information: 16D01,16D02, 16K01, 17A01, 17B01, 17B02

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reports of product loosening or coming unscrewed from the handle.

Field note

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