Recall Z-0125-2025
XTANT Medical Holdings, Inc · initiated August 21, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Codes / lots: UDI-DI: 00810076563190, Lot: DNI
Reason for recall
Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
FDA-determined cause: Process change control
Action taken
On 8/21/24, recall notices were mailed and emailed to customers who were asked to do the following: 1) Examine affected devices and quarantine any screws with DNI markings. 2) Notify your staff about the recall. If affected devices were further distributed, provide the recall notice to these customers. 3) Complete and return the response forms via email to mdolan@xtantmedical.com
Details
- Recall number
- Z-0125-2025
- Initiated
- August 21, 2024
- Posted by FDA
- October 17, 2024
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 330
- Distribution
- US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
- Recalling firm
- XTANT Medical Holdings, Inc, Belgrade, MT