- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Reason for recall
- The proximal thread depth of the spinal device is out of design specification.
- Affected products (lot / model / serial)
- UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.
- Units affected
- 270 units
- Distribution pattern
- 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.
- Firm location
- Carlsbad, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3226-2026
- Recall initiated
- August 19, 2026
- FDA classification date
- September 18, 2026
- FDA report date
- September 30, 2026
- FDA event ID
- 99691
- Last updated on HTM Vibe
- October 6, 2026
