Recall Z-1620-2024
Seaspine Orthopedics Corporation · initiated February 28, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
Codes / lots: REF/UDI-DI/Lots: MX1-001010/10889981298647/ AW161319D, AW164195D, AW166994D, AW167309D, AW167422D, AW169350F, AW169351F. AMRDXMIS/10889981303297/ AMRDXMIS-001, AMRDXMIS-002, AMRDXMIS-003, AMRDXMIS-004, AMRDXMIS-005
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
On 2/26/24, the firm phoned customers and informed them of the recall and that they would receive an email outlining details of the field action and subsequent steps to be taken. On 2/28/24, recall emails were sent to customers asking customers to respond to the emails to coordinate product return and replacement. Customers with questions can contact the firm at olivia.disanto@seaspine.com.
Details
- Recall number
- Z-1620-2024
- Initiated
- February 28, 2024
- Posted by FDA
- April 23, 2024
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 444 Screw Heads
- Distribution
- US: CA, FL, CO, TX
- Recalling firm
- Seaspine Orthopedics Corporation, Carlsbad, CA