Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Reported: February 7, 2024 Initiated: November 28, 2023 #Z-0846-2024
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.
Details
- Recalling Firm
- XTANT Medical Holdings, Inc
- Units Affected
- 6
- Distribution
- US distribution in MI.
- Location
- Belgrade, MT
Frequently Asked Questions
What product was recalled? ▼
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.. Recalled by XTANT Medical Holdings, Inc. Units affected: 6.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 7, 2024. Severity: Moderate. Recall number: Z-0846-2024.
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