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FDA (Device enforcement)Recalled 2017-05-12closedclass ii

DePuy Mitek, Inc., a Johnson & Johnson Co.: DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent should

Is my product affected?

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

  • UPC 10886705026890

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

What happened

DePuy Mitek, Inc., a Johnson & Johnson Company, is recalling the DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver (Product Code 288211), which is used to treat recurrent shoulder conditions. The Combo Screw Driver tip has the potential to break during surgery when used at an angle off-axis to the screw. A total of 173 units were distributed across multiple U.S. states (Arizona, California, Colorado, Georgia, Massachusetts, Michigan, Ohio, and Washington) and international locations (Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, and the UK). The affected lot codes are 16D02, 16E01, 16J01, 17A01, 17B01, and 17B02.

The source document does not specify what actions affected consumers or healthcare facilities should take in response to 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: 173 units Lot/code info: GTN: 01)10886705026890 Lot codes: 16D02, 16E01, 16J01, 17A01, 17B01, 17B02

Source

Official record: FDA (Device enforcement) ↗

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

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