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.
FDA Recall Z-0197-2015 · Posted 2014-11-08
Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeKWS
Date Initiated2014-10-24
Date Terminated2015-07-21
Product Quantity12 units
Reason for Recall
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.
Firm Action
The recalling firm will notify their consignees via letter delivered by traceable courier service. The consignee will be asked to complete and return a form to the recalling firm stating if they have affected product or not.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution including the states of TX, CA, OH, MS, VA, IL, TN, GA, CA, FL, and AZ.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.