Recall Z-1605-2024
Seaspine Orthopedics Corporation · initiated February 15, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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
Details
- Recall number
- Z-1605-2024
- Initiated
- February 15, 2024
- Posted by FDA
- April 22, 2024
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 1579 Screw Heads
- Distribution
- US Nationwide distribution in the states of MI, GA, VA, IN, FL.
- Recalling firm
- Seaspine Orthopedics Corporation, Carlsbad, CA