PlainRecalls
FDA Devices Moderate Class II Terminated

DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

Reported: June 28, 2017 Initiated: May 12, 2017 #Z-2616-2017

Product Description

DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 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

Details

Units Affected
184 units
Distribution
US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK
Location
Raynham, MA

Frequently Asked Questions

What product was recalled?
DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft. Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co.. Units affected: 184 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on June 28, 2017. Severity: Moderate. Recall number: Z-2616-2017.