Z-1492-2019 Class II Terminated
FDA device recall Z-1492-2019 was initiated by K2M, Inc on April 18, 2019 and is designated Class II. Reason for recall: The products are mislabeled. The recall status is terminated (terminated June 19, 2020). Affected quantity: 462 total.
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2019
- Initiation Date
- April 18, 2019
- Termination Date
- June 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 462 total
Product Description
Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
Reason for Recall
The products are mislabeled.
Distribution Pattern
The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.
Code Information
All lots in distribution