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Class 2 Device Recall SeaSpine Mariner RDX System |
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Date Initiated by Firm |
February 15, 2024 |
Date Posted |
April 22, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1605-2024 |
Recall Event ID |
94164 |
510(K)Number |
K222110
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Product Classification |
Thoracolumbosacral pedicle screw system - Product Code NKB
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Product |
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. REF: MX1-000070, part of Mariner RDX Alpha Instruments and Implants, REF: AMRDX and Mariner RDX TD Alpha Implants, REF: AMRDXTD, which are pedicle screw systems.
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Code Information |
REF/UDI-DI/Lots:
MX1-000020/10889981289751/AW161073C, AW164798D, AW164799D, AW164800E, AW164801E;
MX1-000030/10889981289768/AW164802F, AW164803G, AW157588F, AW161074F, AW163331F;
MX1-000040/10889981289775/AW157589D, AW164806E;
MX1-000050/10889981289782/AW164807G, AW164808G, AW164809H, AW157590G, AW172902H;
MX1-000060/10889981289799/AW157591D, AW161076E, AW164811E;
MX1-000070/10889981289805/AW163350G, AW164812G, AW157592G, AW161077G;
AMRDX/10889981291266/AMRDX-001, AMRDX-002, AMRDX-003, AMRDX-004, AMRDX-005, AMRDX-008, AMRDX-009;
AMRDXTD/10889981295332/AMRDXTD-003, AMRDXTD-004, AMRDXTD-005 |
Recalling Firm/ Manufacturer |
SEASPINE ORTHOPEDICS CORPORATION 5770 Armada Dr Carlsbad CA 92008-4608
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For Additional Information Contact |
760-224-0177
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Manufacturer Reason for Recall |
Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
On 2/14/24 the firm phoned distributors and informed them of the recall issue and next steps. On 2/16/24 the firm sent a recall communication via email. Customers were asked to arrange for the return of these sets along with any additional Mariner RDX inventory using a firm provided return label.
Customers with questions or concerns can contact the Associate Product Manager, at olivia.disanto@seaspine.com |
Quantity in Commerce |
1579 Screw Heads |
Distribution |
US Nationwide distribution in the states of MI, GA, VA, IN, FL. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = NKB and Original Applicant = SeaSpine Orthopedics Corporation
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