Integra Titan Reverse Shoulder System right and left recall
Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5…
Why was Integra Titan Reverse Shoulder System right and left 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers PM0278 and PM0277
- Product
- Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 12 units
- Distribution
- Nationwide Distribution including the states of TX, CA, OH, MS, VA, IL, TN, GA, CA, FL, and AZ.
- Recall date
- November 19, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)