Stryker UniVise Spinous Process Fixation Plate System recall
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
Why was Stryker UniVise Spinous Process Fixation Plate System recalled?
The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
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?
Reference Number 48590100 Lots B40155, B34446, B34447 and B41171.
- Product
- Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
- Recalling firm
- Stryker Spine
- Quantity
- 41 units
- Distribution
- Nationwide Distribution.
- Recall date
- November 11, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)