Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
This recall is currently active, issued October 17, 2024. It was issued by Xtant Medical Holdings, Inc.
- Company
- Xtant Medical Holdings, Inc
- Recall Initiated
- August 21, 2024
- Posted
- October 17, 2024
- Recall Number
- Z-0125-2025
- Quantity
- 330
- Firm Location
- Belgrade, MT
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
Lot / Code Info
UDI-DI: 00810076563190, Lot: DNI
Root 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