# FDA recall Z-1808-2021

> **Alphatec Spine, Inc.** · Class II · device recall initiated 2021-04-26.

## Product

Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378

## Reason for recall

There is a potential for the screw blocking mechanism on the  anterior cervical plate system  to disassociate intraoperatively/postoperatively or unlock postoperatively.

## Distribution

US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA,  HI, ID, MA, SC, NM, and NY.

## Key facts

- **Recall number:** Z-1808-2021
- **Recalling firm:** Alphatec Spine, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-26
- **Report date:** 2021-06-16
- **Termination date:** 2022-11-17

- **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-1808-2021

## Citation

> AI Analytics. FDA recall Z-1808-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1808-2021. Source: US FDA. Licensed CC0.

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