DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set i…

Recall date

May 12, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2619-2017

FDA classification

Class II

Brand / firm

DePuy Mitek, Inc., a Johnson & Johnson Co.

Sold / distributed

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

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft