Z-0846-2024 Class II Ongoing
FDA device recall Z-0846-2024 was initiated by XTANT Medical Holdings, Inc on November 28, 2023 and is designated Class II. Reason for recall: Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5… The recall status is ongoing. Affected quantity: 6.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2024
- Initiation Date
- November 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Reason for Recall
Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
Distribution Pattern
US distribution in MI.
Code Information
UDI-DI: 00810076564005, Lot: AP23000143