FDA-Device2014-11-19Class II
Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder System. It is used to project the osteotomy angle on the humeral head.
Integra LifeSciences Corp.
Hazard
A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly. Specifically, the threaded handle has been welded backwards on the template resulting in the cutting angle being the reverse of what it should be.
Sold states
Nationwide Distribution including the states of TX, CA, OH, MS, VA, IL, TN, GA, CA, FL, and AZ.
Affected count
12 units
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder System. It is used to project the osteotomy angle on the humeral head.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0197-2015Don't want to check this manually?
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