Recall Z-0197-2015 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Integra LifeSciences Corp.
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.
| Date | Nov 8, 2014 (initiated Oct 24, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 12 units |
| Distribution | Nationwide Distribution including the states of TX, CA, OH, MS, VA, IL, TN, GA, CA, FL, and AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100448 | ASCENSION MODULAR TOTAL SHOULDER SYSTEM Ascension Orthopedics, Inc., Aug 30, 2010 |