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U.S. Department of Health and Human Services

Class 2 Device Recall Mariner RDX MIS Polyaxial Head

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  Class 2 Device Recall Mariner RDX MIS Polyaxial Head see related information
Date Initiated by Firm February 28, 2024
Date Posted April 23, 2024
Recall Status1 Open3, Classified
Recall Number Z-1620-2024
Recall Event ID 94306
510(K)Number K222110  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
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.
Code Information 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
Recalling Firm/
Manufacturer		 SEASPINE ORTHOPEDICS CORPORATION
5770 Armada Dr
Carlsbad CA 92008-4608
For Additional Information Contact
760-224-0177
Manufacturer 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 2		 Nonconforming Material/Component
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 olivia.disanto@seaspine.com.
Quantity in Commerce 444 Screw Heads
Distribution US: CA, FL, CO, TX
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = SeaSpine Orthopedics Corporation
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