Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System
FDA device recall Z-0197-2015 · posted 2014-11-08 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 12 units
- Distribution
- Nationwide Distribution including the states of TX, CA, OH, MS, VA, IL, TN, GA, CA, FL, and AZ.
- Date initiated
- 2014-10-24
- Date posted
- 2014-11-08
- Date terminated
- 2015-07-21
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASCENSION MODULAR TOTAL SHOULDER SYSTEM (K100448) | Ascension Orthopedics, Inc. | 2010-08-30 |