DePuy Mitek, Inc., a Johnson & Johnson Co.: DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent sh

Is my product affected?

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

• UPC 10886705026807

Check against the official notice below — it lists the full affected range.

What happened

DePuy Mitek, Inc., a Johnson & Johnson company, has recalled 184 units of the Combo Screw Driver (Product Code 288211) used with the Latarjet Cortical Screw set, which is intended to treat recurrent shoulder issues. The screw driver tip has an increased potential to break during surgery when used at an angle off-axis to the screw. The affected products were distributed in the United States (Arizona, California, Colorado, Georgia, Massachusetts, Michigan, Ohio, and Washington) and internationally (Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, and the United Kingdom). The recalled lot codes are 16C01, 16E03, 16R01, 17A01, and 17B01.

The source document does not specify what action affected consumers or medical facilities should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 from the source

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 Quantity: 184 units Lot/code info: GTN: 01)10886705026807 Lot codes: 16C01, 16E03, 16R01, 17A01, 17B01

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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 graft2017-05-12
• 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 graft2017-05-12
• DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft2017-05-12
• 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 graft2017-05-12
• Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and obli2017-05-11

All FDA (Device enforcement) recalls