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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

SeaSpine Reef TA Inserters Recalled for Implant Positioning Issues

Agency Publication Date: September 11, 2025
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Summary

SeaSpine Orthopedics Corporation is recalling 74 Reef TA Inserters (Part Number TA2-001003), which are surgical instruments used as part of the Reef Interbody System for spinal fusion procedures. The inserter may fail to release the spinal implant correctly or cause the implant to be positioned improperly, which can lead to longer surgery times or the need to redo parts of the procedure during surgery. Some devices may also be labeled with incorrect identification markings. Consumers should contact their surgical facility or the manufacturer to ensure these devices are removed from use.

Risk

If the inserter does not disengage or positions the implant incorrectly, it can cause surgical delays and require surgeons to perform revisions or use alternative instruments during the procedure.

What You Should Do

  1. This recall involves the Reef TA Inserter (Part Number TA2-001003), which is a surgical tool used with the Reef Interbody System spinal fusion device.
  2. Check surgical inventory for inserters with lot numbers BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, or BT112779CR2.
  3. The affected devices may also have incorrect identification markings, specifically UDI-DI numbers 10889981290733 or 10889981437800.
  4. Stop using the recalled device. Contact SeaSpine Orthopedics Corporation or your authorized distributor to arrange for the return, replacement, or correction of the instrument.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Reef TA Inserter (part of the Reef Interbody System)
Model / REF:
TA2-001003
Lot Numbers:
BT107376C
BT112289C
BT112779C
BT107376CR1
BT107376CR2
BT107376CR1R2
BT112289CR2
BT112779CR2
UDI:
10889981290733
10889981437800

Used as part of a system with an intervertebral body fusion device.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97190
Status: Active
Manufacturer: SEASPINE ORTHOPEDICS CORPORATION
Sold By: Medical Distributors; Hospitals; Surgical Centers
Manufactured In: United States
Units Affected: 74
Distributed To: Nevada, Texas, Idaho, Michigan, Ohio, South Dakota, Tennessee, Pennsylvania, Connecticut, Colorado, Florida, Washington, North Carolina, Oklahoma, Minnesota

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 ยท 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.