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
Reported: June 28, 2017 Initiated: May 12, 2017 #Z-2615-2017
Product Description
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
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
Details
- Recalling Firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Units Affected
- 173 units
- Distribution
- US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK
- Location
- Raynham, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co.. Units affected: 173 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 28, 2017. Severity: Moderate. Recall number: Z-2615-2017.
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