Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
FDA Recall Z-1620-2024 · Posted 2024-04-23
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Recalling FirmSEASPINE ORTHOPEDICS CORPORATION
Recall StatusOpen, Classified
Product CodeNKB
Date Initiated2024-02-28
Product Quantity444 Screw Heads
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.
Firm Action
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 [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
US: CA, FL, CO, TX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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