FDA Medical Device Recalls (openFDA)
SEASPINE ORTHOPEDICS CORPORATION: SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
- Recall number
- Z-3226-2026
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Product
- SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
- Status
- Open, Classified
- Initiated
- 2026-08-19
- Posted
- 2026-09-18
- Terminated
- not on file
- Reason
- The proximal thread depth of the spinal device is out of design specification.
- Root cause
- Process design
- Action
- 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.
- Quantity
- 270 units
- 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.
- Lot, serial or model codes
- UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.
- 510(k) numbers
- ["K211606"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3012120772
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28