Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT recall
Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
Why was Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT recalled?
Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
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?
GTIN/UPN: 643169329218 Lot Number: H5399679
- Product
- Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 39 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)