# FDA recall Z-1410-2021

> **K2M, Inc** · Class II · device recall initiated 2021-03-16.

## Product

Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine)  Catalog number: 3608-90033

## Reason for recall

Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies

## Distribution

PA

## Key facts

- **Recall number:** Z-1410-2021
- **Recalling firm:** K2M, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-16
- **Report date:** 2021-04-21
- **Termination date:** 2021-08-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Leesburg, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1410-2021

## Citation

> AI Analytics. FDA recall Z-1410-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1410-2021. Source: US FDA. Licensed CC0.

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