Quick Facts at a Glance
- Recall Date
- August 6, 2025
- Hazard Level
- HIGH
- Brand
- SeaSpine Orthopedics
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- SeaSpine Orthopedics
- Product type
- Spine Surgery Inserter Instrument
- Model numbers
- 10889981290733, 10889981437800, BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2 +2 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 6, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEASPINE ORTHOPEDICS CORPORATION or your healthcare provider for instructions. Notification method: Letter
About This Product
The Reef Interbody System is a spine fusion device used in surgical procedures. The Reef TA Inserter is an accompanying instrument designed to position the interbody device during surgery.
Why This Is Dangerous
The inserter may cause difficulty disengaging the implant or improper positioning, which can lead to longer surgeries and possible intraoperative revisions. Incorrect UDI-DI markings may complicate device identification and recalls.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and surgeons must audit instrument kits to ensure only non-recalled devices are used. Delays or revisions can impact operating room schedules and patient recovery timelines.
Practical Guidance
How to identify if yours is affected
- Verify Part Number TA2-001003 against inventory lists
- Confirm device details with the facility’s sterile processing department or procurement records
- Consult the recall notice for additional identifiers and instructions
Where to find product info
UDI-DI markings are on device labels and packaging. Part numbers and model codes are on instrument handles and documentation provided with the Reef Interbody System.
What timeline to expect
Not specified by the manufacturer.
If the manufacturer is unresponsive
- Document all requests for instructions and dates.
- Escalate to hospital risk management and the supplier.
- File a report with the appropriate regulatory body if needed.
How to prevent similar issues
- Verify UDI-DI and part numbers before use in procedures.
- Maintain an up-to-date recall audit list for spine implants and instruments.
- Require recall notifications from vendors before procurement and usage.
Documentation advice
Keep recall letter, FDA notice, device labels, serials, and all correspondence with the manufacturer.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Part Number: TA2-001003 UDI-DI: 10889981290733 and 10889981437800 Other model codes: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2 Quantity recalled: 74 Sold worldwide; US distribution includes NV, TX, ID, MI, OH, SD, TN, PA, CT, CO, FL, WA, NC, OK, MN and Hong Kong Price: Unknown Sold since: Unknown Country of origin: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Part Number TA2-001003
- Distributed worldwide including specific US states and Hong Kong
- High hazard level; potential to prolong surgery or require intraoperative revision
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
