Recalls / —
—#131021
Product
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 product code
- KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K100448
- Affected lot / code info
- Lot Numbers PM0278 and PM0277
Why it was recalled
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 (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- Nationwide Distribution including the states of TX, CA, OH, MS, VA, IL, TN, GA, CA, FL, and AZ.
Timeline
- Recall initiated
- 2014-10-24
- Posted by FDA
- 2014-11-08
- Terminated
- 2015-07-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #131021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.