Z-2615-2017 Class II Terminated

Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. — Raynham, MA

Recall Details

Product Type
Devices
Report Date
June 28, 2017
Initiation Date
May 12, 2017
Termination Date
October 3, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
173 units

Product Description

DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 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 Pattern

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

Code Information

GTN: 01)10886705026890 Lot codes: 16D02, 16E01, 16J01, 17A01, 17B01, 17B02