# FDA recall Z-2762-2026

> **SEASPINE ORTHOPEDICS CORPORATION** · Class II · device recall initiated 2026-05-28.

## Product

SeaSpine Polyaxial Head  REF Number: 41-3010

## Reason for recall

Due to manufacturing error, polyaxial  head may popoff  from the screw intraoperatively following insertion.

## 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.

## Key facts

- **Recall number:** Z-2762-2026
- **Recalling firm:** SEASPINE ORTHOPEDICS CORPORATION
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-28
- **Report date:** 2026-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2762-2026

## Citation

> AI Analytics. FDA recall Z-2762-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2762-2026. Source: US FDA. Licensed CC0.

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