DePuy Mitek, Inc., a Johnson & Johnson Co.: DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder i

Is my product affected?

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

• UPC 10886705026791

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

What happened

DePuy Mitek, Inc., a Johnson & Johnson company, has recalled the Combo Screw Driver (Product Code 288211), which is part of the Latarjet Cortical Screw set used to treat recurrent shoulder dislocation. The screw driver tip has an increased potential to break during surgery when being used at an angle that is off-axis to the screw. A total of 184 units were distributed across multiple U.S. states (Arizona, California, Colorado, Georgia, Massachusetts, Michigan, Ohio, and Washington) and several foreign countries (Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, and the United Kingdom).

The affected product has lot codes 16C01, 16E01, 16E02, 16E03, and 17B01. The FDA record does not specify a remedy or recommended consumer action.

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)10886705026791 Lot Codes: 16C01, 16E01, 16E02, 16E03, 17B01

Source

Official record: FDA (Device enforcement) ↗

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

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