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
Check against the official notice below — it lists the full affected range.
DePuy Mitek, Inc., a Johnson & Johnson company, is recalling 115 units of the Combo Screw Driver (Product Code 288211) used with the Latarjet Cortical Screw set, which is intended to treat recurrent shoulder conditions. 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 units are identified by Global Trade Item Number (GTN) 01)10886705026944 with lot codes 16D01, 16D02, 16E02, 16J01, 17B02, 17B03, and 17B04. The source document does not specify a remedy or required action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: 115 units Lot/code info: GTN: 01)10886705026944 Lot codes: 16D01, 16D02, 16E02, 16J01, 17B02, 17B03, 17B04
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.