Mariner recallZ-2762-2026 · Seaspine Orthopedics Corporation · initiated May 28, 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
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
FDA root cause category: Process change control
What the company is doing
On June 16, 2026, Orthofix issued a updated Urgent Medical Device Recall notification to provide additional information concerning the recall. Initial notification was issued on May 28, 206. Orthofix ask consignees to take the following actions: 1. Discontinue use of affected lots, 2.Immediately 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-2762-2026
- Status
- Open, Classified
- Initiated by the company
- May 28, 2026
- Posted by the FDA
- Jul 20, 2026
- Recalling firm
- Seaspine Orthopedics Corporation
- Quantity
- 796 units
- Product code
- NKB
- FDA submissions
- K173882
- Distribution
- Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Mississippi, Montana, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wyoming. The countries of Chile and Australia.
Product description
SeaSpine Polyaxial Head REF Number: 41-3010
Code information (models, lots, serial numbers)
UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Mariner 41-3010Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall1 report
Product lines
Other devices under the same FDA submission
1 device cleared under K173882 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Mariner 41-1010Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 death85 reports
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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