FDA recall Z-2363-2023
Medtronic Sofamor Danek USA, Inc · Class II · device
Product
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Reason for recall
Incorrect Laser Marking - Solera Awl Tip Tap
Distribution
US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-07-12
- Report date
- 2023-08-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Memphis, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2363-2023