Pedicle Screw Heads Recalled Due to Cross-Threading Risk During Surgery
SeaSpine's Mariner RDX MIS pedicle screw heads may have partial threading that causes cross-threading at the screw head interface during implant installation. Affected units distributed in CA, FL, CO, and TX.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a surgical implant with a documented manufacturing defect that poses intraoperative risk. No injuries or illnesses have been reported. This meets the criteria for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
SeaSpine Orthopedics Corporation is recalling 444 Mariner RDX MIS Polyaxial Head screw units due to a manufacturing defect that creates a surgical risk.
The affected screw heads contain partial threading within the component that can cause cross-threading at the locking cap and screw head interface during surgical installation. This defect poses a risk of intraoperative complications during pedicle screw placement procedures.
The recalled units were distributed in California, Florida, Colorado, and Texas. Affected product lots include REF MX1-001010 with UDI-DI 10889981298647 (lots AW161319D, AW164195D, AW166994D, AW167309D, AW167422D, AW169350F, AW169351F) and AMRDXMIS kits with UDI-DI 10889981303297 (lots AMRDXMIS-001 through AMRDXMIS-005).
Hospitals and surgical facilities should identify and quarantine affected inventory immediately. Contact SeaSpine Orthopedics Corporation for instructions on product return or replacement.
The recalled product
- 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.
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Affected units
- 444
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
Distribution
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