Mariner Deformity recallZ-3226-2026 · Seaspine Orthopedics Corporation · initiated Aug 19, 2026
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
The proximal thread depth of the spinal device is out of design specification.
FDA root cause category: Process design
What the company is doing
On August 19, 2026, SeaSpine Orthopedics Corporation a subsidiary Orthofix issued a Urgent Medical Device Recall Notification via Email. SeaSpine ask consignees to take the following actions: Actions to be taken by the Customer/User: 1Discontinue use of affected lots 2Immediately identify and quarantine any affected product 3. If product is identified, Orthofix will facilitate the return 4.Complete and return the attached Acknowledgement and Receipt Form 5.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.
Recall details
- Recall number
- Z-3226-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 19, 2026
- Posted by the FDA
- Sep 18, 2026
- Recalling firm
- Seaspine Orthopedics Corporation
- Quantity
- 270 units
- Product code
- NKB
- FDA submissions
- K211606
- Distribution
- US Nationwide distribution in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas, and Virginia.
Product description
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
Code information (models, lots, serial numbers)
UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Mariner Deformity MD1-300010-12Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K211606 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Mariner Deformity MD1-115535Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 report
- Mariner Deformity MD1-136550Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 report
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.
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