Yukon Polyaxial Screw recall
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Why was Yukon Polyaxial Screw recalled?
The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
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?
Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582
- Product
- Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
- Recalling firm
- K2M, Inc
- Quantity
- 248 units/1 each
- Distribution
- Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore
- Recall date
- February 3, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)