SEASPINE ORTHOPEDICS CORPORATION: Mariner RDX MIS Pedicle Screw Heads Recalled for Cross-Threading Risk

Agency Publication Date: April 23, 2024

Summary

SeaSpine Orthopedics Corporation is recalling 444 Mariner RDX MIS Polyaxial Heads and Alpha Instruments/Implants used in spinal surgeries. These pedicle screw systems may contain partial threads within the screw head that prevent the locking cap from securing correctly. This defect was identified in specific lots of the Mariner RDX MIS system, which are used to provide immobilization and stabilization of spinal segments. If you or a loved one have undergone a recent spinal procedure involving these components, you should contact your surgical team to discuss the implications of this recall.

Risk

The defective internal threads can cause intraoperative cross-threading, making it difficult or impossible to properly secure the locking cap to the screw head during surgery. This can result in an unstable spinal construct, potentially leading to surgical delays or the need for additional procedures to replace the faulty hardware.

What You Should Do

Review your surgical records or contact your healthcare provider to determine if Mariner RDX MIS Polyaxial Heads (REF: MX1-001010) or Alpha Instruments and Implants (REF: AMRDXMIS) were used in your procedure.
Check for affected Polyaxial Head lot numbers: AW161319D, AW164195D, AW166994D, AW167309D, AW167422D, AW169350F, and AW169351F.
Check for affected Alpha Instrument and Implant kit lot numbers: AMRDXMIS-001, AMRDXMIS-002, AMRDXMIS-003, AMRDXMIS-004, and AMRDXMIS-005.
Patients who have already had these devices implanted should follow their surgeon's standard post-operative care instructions; however, if you experience new or unusual back pain or instability, contact your physician immediately.
Healthcare facilities should identify and quarantine any remaining unused inventory of these specific lot numbers and contact SeaSpine Orthopedics Corporation for return instructions.
Contact SeaSpine Orthopedics Corporation or your healthcare provider for further instructions regarding this recall and potential next steps.
For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Mariner RDX MIS Polyaxial Head

Model / REF:

MX1-001010

UPC Codes:

10889981298647

Lot Numbers:

AW161319D

AW164195D

AW166994D

AW167309D

AW167422D

AW169350F

AW169351F

Product: Mariner RDX MIS Alpha Instruments and Implants

Model / REF:

AMRDXMIS

UPC Codes:

10889981303297

Lot Numbers:

AMRDXMIS-001

AMRDXMIS-002

AMRDXMIS-003

AMRDXMIS-004

AMRDXMIS-005

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94306

Status: Active

Manufacturer: SEASPINE ORTHOPEDICS CORPORATION

Sold By: Authorized medical distributors; Specialty surgical centers

Manufactured In: United States

Units Affected: 444 Screw Heads

Distributed To: California, Florida, Colorado, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Review your surgical records or contact your healthcare provider to determine if Mariner RDX MIS Polyaxial Heads (REF: MX1-001010) or Alpha Instruments and Implants (REF: AMRDXMIS) were used in your procedure.

Check for affected Polyaxial Head lot numbers: AW161319D, AW164195D, AW166994D, AW167309D, AW167422D, AW169350F, and AW169351F.

Check for affected Alpha Instrument and Implant kit lot numbers: AMRDXMIS-001, AMRDXMIS-002, AMRDXMIS-003, AMRDXMIS-004, and AMRDXMIS-005.

Patients who have already had these devices implanted should follow their surgeon's standard post-operative care instructions; however, if you experience new or unusual back pain or instability, contact your physician immediately.

Healthcare facilities should identify and quarantine any remaining unused inventory of these specific lot numbers and contact SeaSpine Orthopedics Corporation for return instructions.

Contact SeaSpine Orthopedics Corporation or your healthcare provider for further instructions regarding this recall and potential next steps.

For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Affected Products

Product: Mariner RDX MIS Polyaxial Head

Model / REF:

MX1-001010

UPC Codes:

10889981298647

Lot Numbers:

AW161319D

AW164195D

AW166994D

AW167309D

AW167422D

AW169350F

AW169351F

Product: Mariner RDX MIS Alpha Instruments and Implants

Model / REF:

AMRDXMIS

UPC Codes:

10889981303297

Lot Numbers:

AMRDXMIS-001

AMRDXMIS-002

AMRDXMIS-003

AMRDXMIS-004

AMRDXMIS-005