FDAFDA · Food and drugs·Recall number Z-2619-2017
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
Published June 28, 2017 · Recall initiated: May 12, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Distributor
- US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK
- Lot
- GTN: 01)10886705026944 Lot codes: 16D01, 16D02, 16E02, 16J01, 17B02, 17B03, 17B04
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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