# FDA recall Z-1237-2021

> **RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)** · Class II · device recall initiated 2021-01-15.

## Product

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).

## Reason for recall

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1237-2021
- **Recalling firm:** RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-01-15
- **Report date:** 2021-03-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marquette, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1237-2021

## Citation

> AI Analytics. FDA recall Z-1237-2021. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1237-2021. Source: US FDA. Licensed CC0.

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