SEASPINE ORTHOPEDICS CORPORATION Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
SEASPINE ORTHOPEDICS CORPORATION
Lot Codes / Batch Numbers
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
Products Sold
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
SEASPINE ORTHOPEDICS CORPORATION is recalling Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Impla due to Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, TX
Page updated: Jan 10, 2026