FDA-Device2024-05-01Class II
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
SEASPINE ORTHOPEDICS CORPORATION
Hazard
Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Sold states
US: CA, FL, CO, TX
Affected count
444 Screw Heads
Manufactured in
5770 Armada Dr, N/A, Carlsbad, CA, United States
Products
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1620-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief