Recall Z-0846-2024— XTANT Medical Holdings, Inc
Class II · Ongoing
Class II FDA medical device recall by XTANT Medical Holdings, Inc, initiated 2023-11-28. It names one FDA 510(k) clearance: K221403. Product: Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.. Reason: 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..
- Recalling firm
- XTANT Medical Holdings, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-28
- Firm location
- Belgrade, MT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.