Reef TA recallZ-2554-2025 · Seaspine Orthopedics Corporation · initiated Aug 6, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Seaspine Orthopedics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
On 8/6/2025, recall notices were emailed to customers and distributors who were informed of the following: A laser marking error was identified in which the TA2-001003 inserters were incorrectly marked with the UDI-DI for model TA2-001002 (10889981290733). Updated Revision E Inserters have been shipped to you via overnight delivery. Kindly replace all existing Revision C/R1/R2 Inserters with the enclosed Revision E units. Return the Revision C Inserters to the recalling firm using provided RGA and prepaid shipping label. This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. Should you have any questions regarding this matter, please contact the firm at: [email protected]
Recall details
- Recall number
- Z-2554-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 6, 2025
- Posted by the FDA
- Sep 11, 2025
- Recalling firm
- Seaspine Orthopedics Corporation
- Quantity
- 74
- Product code
- MAX
- FDA submissions
- K192132
- Distribution
- Worldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH, SD, TN, PA, CT, CO, FL, WA, NC, OK, MN and the country of Hong Kong.
Product description
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Code information (models, lots, serial numbers)
UDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Reef TA TA2-001002Seaspine Orthopedics Corporation · Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Reef TA TA2-001003Seaspine Orthopedics Corporation · Intervertebral fusion device with bone graft, lumbar1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page