FDA recall Z-2617-2017

DePuy Mitek, Inc., a Johnson & Johnson Co. · Class II · device

Product

DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

Reason for recall

Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw

Distribution

US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK

Key facts

Status: Terminated
Initiation date: 2017-05-12
Report date: 2017-06-28
Termination date: 2018-10-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2617-2017